Pharmaceutical equivalence of drugs. Relevant topic is the equivalence of drug workers: pharmaceutical aspects

problem of interoperability lykarsky zasobiv (LZ) in Danish hour to negotiate to do it actively at the very rіvnya rіvnya and in our country, and beyond the cordon. Vona may be purely therapeutic, so to complete the actual economic basis. It means that in our country there is still a lot of clear definition of reciprocal drugs. The interpretation of the ts'ogo pundit is much more deeply rooted in the thoughts of the young factions and to the knowledge of the LZ by them. Calling a different term to the whole term can be recognized in the event of a visit to a therapeutic institution and a factory, connected from the purchase of licars for state contracts.

Instead, we will focus on doing specific aspects of the problem and interoperability. From a therapeutic point of view, it is obvious that two different LZs (to replace two different dialects) of the same pharmacological group can replace one for thinking, but the smell may, for example, be the same mechanism of the same blocking mechanism (say, quietly) It is necessary to determine the correct dosage and frequency of intake. In the first place, two LZs for the drug will be interchangeable: there is no way to sell one at a time, and it is worth noting that. This is the name of the therapeutic substitution, but the understanding of interdependence is not the same. In the Danish hour of the term it is necessary to replace the original drug with a generic, or replace one generic with the one with the most common speech. In general, at least, the same homeliness. And the axis of both original preparations and generics should be taken into account by mutual problems and problems and will be on the way of new nutrition, and will be discussed in this statute.

The problem of the equivalence of produced drugs (generics) is costly to add a great number of drugs to the market. The price of food is relevant in all the world, albeit in our land, in the last two decades, having added special significance, some of them were not ready for the majestic flow of LZ. Our regulatory system, scientific base, and all the understanding of the boule are adapted for the market, which is the result of the deficiency of the LZ. Now the situation has changed dramatically. Russian pharmaceutical market of drugs with a great number of drugs. For the deyakim of diyuchy rechovins (paracetamol, acetylsalicylic acid, diclofenac sodium, metamizol sodium, enalapril maleate, ciprofloxacin hydrochloride and in.) The number of specific drugs in the troche has decreased, and the problem of generics is not known in the world.

Who has a pole for food? Adequate surplus of goods is guilty of receiving the competition, fighting for the customer by the way of increasing the quality of the product and reducing the price. In the first place, in the general statistics, we will use the words "goods", we will talk about LZ, so about products, as they have unique power, for which the first critics, efficiency All the same, it is inherited - and the price of drugs, and health, like my rizykumo to spend, stagnant LZ, but do not think of any vimogam.

Vimogi to LZ

By fixing the negotiation before the assessment of the reciprocity of the LZ, please send a quote from the International Pharmaceutical Federation (FIP, www.fip.org) and the International Federation of Pharmaceutical Companies, in 1999. , in the wake, it’s about those, that the replacement of the original drug on the basis of the product “is guilty of being carried out only in that case, if the reason is accepted by international standards, including bioequivalence, because of the guarantee.

In many documents, it will be said: “All guilty parties are guilty of living in before the safety of the quality, safety and efficiency of all medical devices available from the leading powers, according to the accepted international standards. The price is applied both to the original ones, to the production of drugs, to the private and state sectors, and to the imported and viroblended products on the global market of products. "

Such a rank, before any LZ, is presented by three vimogas: efficiency, safety and quality. Such a pidhid before the assessment of the LZ in the given hour was accepted in the United States, incl. and in our land.

The category of "efficiency" and "safety" is considered to be medical and biological nutrition, and the "quality" is a purely pharmaceutical problem and the view of the perception of medical personnel in the normative documentation for indicators of authenticity speeches (or speeches in times combined drug). Due to the safety and quality control of the medicinal product, the rules of good viral practice (GMP) were tied.

Original and updated LZ. Basic terms

It takes an hour to discuss the nutritional relationship between LZ and the main terms. Under the Federal Law No. 61-FZ "On the problem of pharmaceutical substances", it is given the following values: In the foreign literature, it is possible to develop different terms "innovator product", "branded product". In the documents of the VOOZ “innovator pharmaceutical product” - the whole product, for the first time the permissions are stipulated on the basis of documentation about its quality, safety and efficiency.
The organization, which has broken the original LZ, will turn it off for a new patent holder for a trivial period (up to 20 years and more), which will allow you to compensate for a lot of vitractions for the boxing for the first time on the market, and also to remove it. The original LZ may have a higher number of patents per hour and a higher number of patents from generics.

Qia obstavina wiklikak post criticism. To be sure, the vitrati declared by the provincial virobniks for the development of a new LZ (that is, a new molecule) is clearly envious, as it is unjustifiably envious of the original copy of the patent.

Ale do not zabuvati, scho, in Pershe, the current LZ may be more subtle, straightened, vibrant mechanics of the diy, niz kosty, for example, s quiet pharmacological groups, Ale is broken after ten years. Tom should be able to see during the day-to-day screening of active speeches, so that in a row of vipadks it is possible to speed up the hour of a new active molecule, a joke, multiplication by the number of victorious high-tech technologies, to wrap up

In other words, we will not get overwhelmed by repeating, but the main locomotive for the development of pharmaceutical galusa є virobniki of the innovative LZ. A slid of memory, so an arrival, obsessions during the implementation of original preparations, go to the kintsev rakhunka, to the distribution of the innovations of lykarsky zasobiv.

Vidtvorene LZ - LZ, why revenge the same pharmaceutical substance or a combination of the same pharmaceutical substances in the same lykarskiy form, Which is the original LZ, and it was necessary to be done in order to be able to do it in the original LZ. The term “generic” or “generic” (generic product) is also commonly used.

It is worth mentioning that in the documents of the WHO (www.who.int), in connection with the various interpretations in the rural regions of the term “generics”, it is recommended to use the term “multisource pharmaceutical products”. VOOZ is a form of pharmaceutical equivalent or pharmaceutical alternative drugs, which may or may not be therapeutically equivalent. The term "multi-source", I wish it is not even more sweet-sounding and does not get along with the vichiznyany of terminology, a little more concretely the reasoning of the fact that drugs are produced from pharmaceutical substances and additional, similar speech. Tobto zbirayutsya, yak a designer, - from the details of the new virobniks. Oskіlki theoretically post-bosses can easily change, then even є drive for criticism from the side of the virobniks of the original LZ. Surely, such a move into a zeal-like mindset accelerates the preservation of one-sided quality, as well as the reasons for efficiency and security.

In general, there is a particular interest in the definition of a generic drug, which is given in the Directive 2001/83 / EC of the European Parliament, as a form of recognition of a vimogi before the licars: generic drug (generic drug) Substances and the same lykarsky form, which is a preparation of a suitable form, and the bioequivalence of such a bullet has been brought by way of carrying out an increase in availability in terms of being brought up to a preparation of porousness. So that the country for the European Union theoretically does not allow the generics to be exposed to the problems of bioequivalence on the market of generics;

According to the prescription of the WHO, pharmaceutical preparations are equivalent to pharmaceuticals, since they should replace the same quantity of one and the same active substance (substance) in the same standards of introduction and the same form of the same pharmaceutical Similarly, but more specifically, from a practical point of view, given by the US FDA (www.fda.gov): drugs are used in pharmaceutical equivalent, which can be used (1) the same active drug in the same dose (2) with the same dose form, (4) values for one way introduced and (5) are based on pharmacopoeial or other established standards in terms of a lot of change, purity and validity.

WHO means that drugs are pharmaceutically alternative, as long as they smell the same amount of one and the same active ear, but they are dispensed according to the drug form (for example, tablets and capsules) and / or any form of chemistry. Pharmaceutical alternatives for one way of introduction. The approved pharmaceutical alternatives have roughly the same requirements as the FDA.

It is necessary to be respected, right up to the present hour in literature, in the Internet, in the mobile device, it is possible to implement the terms “synonyms of LZ”, “analogs of likes”, “substitutes”, etc. We would like to guard the fahivts from the history of the given terminology without a clear meaning to the context, which is indicative of the paths given to them.

For example, the term “synonymy LZ” is incorrect to promote vicoristovuvati according to the name of a generic drug. Tse bulo b hoch in deyakiy world it is true, as it did not eliminate the problem of therapeutic equivalence, interdependence. To that, there can be no synonyms for selling drugs. Alle for substances, it can be used, for example: metamisol sodium as an international non-patented name (INN) and analgin as a pharmacopoeial name, paracetamol as INN and acetaminophen as an international name (US).

bioequivalence of generics

However, the generic formulation, the dosage form, and the way the introduction of the supplementary drugs, the supplementary drugs of the young virobniks, does not mean that the efficiency of the generic drugs is also equal to the storage parameters. / In any case, a viral process can lead to a problem in the effectiveness of these drugs. The whole fact has long been discussed and discussed in the middle of the last century.

As a small step, it is significant that it is often necessary to negotiate nutrition in a house for efficiency and safety of generics. This drive can be said, but at the same standards of cleanliness, laid down in the One State Pharmacopoeia standard for the quality of LZ, the nutrition of the infusion of houses into the zagalny vipad is known. On the right, if such a standard of quality (tobto the State Pharmacopoeia) in the general view is actually mute, and the normative documentation of virobniks (FSP and ND) is actually worthless. At the end of the diet about houses, it’s just as well as about the other parameters of quality, it’s overlooked, so that there is a need for prioritization of the infusion for the efficiency and safety of the drug.

Otzhe, in connection with the heterogeneity of generics, there is a clear understanding of biological equivalence. Here with the documents of the WHO, two drugsє bioequivalent, like the smell є pharmaceutical equivalent or pharmaceutical alternative, and їh bioavailability from the point of view of the maximum concentration in blood plasma (CMAX), the hour of reaching the level of concentration (TMAX) of the same minds are similar to those of the world, in each of the efects є on the same day. Approximately the same message from the European Agency for licenses (EMA, www.ema.europa.eu) and from the FDA.

The WHO and the FDA recommend the initiation of bioequivalence in vivo and in vitro:
- Individual pharmacokinetic vip testing in humans (inoculation of the concentration profile of the drug for any metabolism in biological age);
- individual pharmacodynamic viprobation in humans (vivchennya efektyv, scho viklikayutsya LZ);
- Porіvnyalnі kіnіchnі viprobuvannya;
- in vitro dosage adjustments (for example, the "raskinennya" test).

The word "porous" means that all pererakhovani vische until lddzhennya carried out by way of setting all parameters in viprobuvanny preparation and preparation porіvnyannya.

VOOZ publishes recommendations on the choice of the preparation for living needs. Recommendations include, zokrema, for skin INN Trade name of the original drug, which is recommended to be vicoristovuvati in the form of a drug in the presence of generic drugs. At the same time, it is also possible to induce a variety of medical forms and additions.

In the United States, the vibration of the drug is carried out on the basis of the data presented in the so-called Orange Book, which we will talk about below. They are also given an order for a specific drug in the form of a drug, for a single dose and a specific drug. Preparations, which can be used for testing generics with them, may be marked by the corresponding graph. Є There is also a revision of the documentation, in which instructions are to be made for the conduct of pharmacokinetic dosages and the test "identification" for the assessment of the bioequivalence of medicinal products.

Therapeutic equivalence and interoperability

First and foremost, the best understanding is the therapeutic equivalence. It is more important, that it is the closest to be worth until the reason of that, which preparations can be mutually compatible. Appropriately, according to the WHO definitions, an interchangeable drug is a drug that is therapeutically equivalent when introduced with a drug, and for any drug it is possible to replace it in practice. The same position is depicted in the FDA documents.

We will also be ready to take care of the approach, with any therapeutically equivalent drugs will be interchangeable. It’s only true that it’s true nutrition: which drugs are therapeutically equivalent?

Criteria for therapeutic equivalence

Possibly, from the name of the WHO: “two medicinal drugs are therapeutically equivalent, because the smell є pharmaceutically equivalent, or є pharmaceutically alternative and when they are consumed in one molar dose and the same efficiency ".

Nowadays, the indicated value of therapeutic equivalence, which is given by the FDA: So, in the opinion of the WHO, the FDA considers only pharmaceutical equivalent drugs in the capacity of therapeutic equivalents. Thus, from the point of view of the FDA, capsules and tablets, for example, should not be given therapeutically equivalent in one dose. In addition, the FDA has specifically described all of the therapeutic equivalences for the purpose of providing specific treatment.

1. Likarsky drugs are allowed to be used until they are effective and safe.
2. Preparations for buty pharmaceutical equivalent.
3. Preparations that are guilty of being bioequivalent, so that they are guilty before taking out:
- for them, they do not see any obvious potential problems with bioequivalence, and the stench seems to be in accordance with the standard during in vitro testing.
- for them, there are obvious or potential problems with bioequivalence, it is shown that the stench seems to be in accordance with the bioequivalence standard.
4. Preparations for the guilty mother have proper instructions.
5. Preparations of guilt shall be carried out according to the requirements of the Good Practices (GMP).

The FDA is a kind of document, which I will officially call "Approved Drug Products with Therapeutic Equivalence Evaluations", which can be changed approximately like "Allowed until the consumption of drugs due to their therapeutic equivalence". Briefly, the document was adopted as the title of the Orange Book.

However, we must go to the assessment of the therapeutic equivalence of drugs in specific virobniks and presented by the FDA in general form. Fakhivtsi FDA indicate that the identification of specific codes of therapeutic equivalence can serve as an indicator when replacing one drug for the least and additional help, winter, in the reduced health of the disease. It is also necessary to remember that the main value of the Orange Book of the FDA is in the fact that it has an electronic version, and it is new today.

Slide means that in Danish hour the situation has emerged at the turn of the term, since the test of bioequivalence is based on the importance of the development of the concentration profile of the drug preoccupation. First of all, they are important, but it is not possible to reflect the bioequivalence and therapeutic equivalence, but in some cases it is possible to confirm only by way of carrying out additional pre-service protocols. Overseas documentation is based on uvaz, or it directly implies the ability to understand cich. In addition, in the FDA's Orange Book, the advice on therapeutic equivalence can be put on a positive result in case of bioequivalence immunization by pharmacokinetic approach. The self-sufficiency of such adolescents in a large number of vypadkіv was magnified by the fact that the concentration profile of lykarskoy speech in the blood plasma reflects this in the mіsci diya.

The criteria for therapeutic equivalence that are approved by the FDA are also discussed below. Altogether, it’s important that the FDA pledged to fix the problem of interoperability of drug products in a complete set and most efficiently. Alez obov'yazkovymi vikonannyam all vishchevkazanih minds. It is perceivable that the code of therapeutic equivalence can serve as an interface in the context of “efficiency” and “safety”, as the problem is seen directly in the context of “quality”.

Therapeutic equivalence and GMP

Establishing criteria for therapeutic equivalence (to be mutually beneficial) for drugs, the FDA specifies the need for a GMP test. Tse, madly, even more important. Well, if LZ is not carried out according to GMP standards, the stench cannot be one-sided from a series to a series. First of all, the preparation can be used in all parameters: in terms of quality, efficiency and safety. To this, the therapeutic equivalence for one series of such products is not meant, but all products in the future will meet the necessary bioequivalence standards.

At the same time, there is a need for intelligence, but the state control of quality is not a problem as a whole, it would be possible to change the problem for all exported and imported LZs. To that, in Danish hour in the world of light and in our land, we are talking about the emphasis on the control of the quality of LZ on the safety of quality. Earlier, we also repeatedly ordered those who are at the virobnik on the go-and-go, if the stench goes like this in the process of virobnitting, and not the one that is kind of wrong. Taking into account such a principle, I will pay more attention to the adherence of the enterprise to the GMP (and more), the introduction of the institute for more advanced features, the training of highly qualified personnel before the robotics, the speedy reception of the guest

Here we are also dodamo, which plays a great role in the safe quality of the LZ play the power of the virobnik's resources in the field of scientific advice and distribution. In addition, there are more resources for more development and more efficient interaction with food products, control and safety of quality, in this larger world we can improve the quality of the product in general.

Establishment of equivalence without carrying out dosage

The current position is such that LZ is designated for systemic impairment (lykarska speech is used in systemic blood flow), then pharmacokinetic prerequisites for bioequivalence are required. Even though the drug is not overwhelmed by the emergence of active speech in the systemic blood flow, because it is important by explicit analytical methods, then the necessary pharmacodynamic methods are necessary to bring about new clinical reports.

Ale vynikak food about porvnyannya, for example, inn'kts_ynyh vassob_v. As long as the solutions are already prepared, such as pharmaceutical equivalent drugs and signs for internal administration, then how to establish their therapeutic equivalence and why do you need to take advantage of the cost?

Zgіdno VOZ, made LZs can be used therapeutically equivalent without additional dosages in the onset of the disease.
1. Pharmaceutical preparations for parenteral (intravenous, pediatric or intravenous) administration and are water levels of one and the same active substance in the most molar and similar concentration Singing additional speeches (for example, adding a buffer medium, as well as preserving antioxidants) can be perceived with the onset of a mind: it has been demonstrated that it is not necessary to infuse the safety and / or the ineffectiveness of the preparation.
2. Medicinal preparations are solutions for oral consumption (for example, syrups, elixiri, tinctures), which can be used for one and the same daily concentration in one and the same molar concentration as a day, one day. With a lot of respect, I would come to see the quiet of the auxiliary speeches, which pour into the moisture and stability of the conversation in the slunk-intestinal tract.
3. Lykarsky preparations are powders for preparation of solutions, and for obtaining decisions according to the criteria specified in paragraphs 1 or 2.
4. Lykarsky drugs є gases.
5. Vushnі and ochnі medicinal preparations, such as є water issues and place one and the same active substance (substance) in one and the same molar concentration and, according to the day, one and the same additional words in different concentrations. Singing additional speeches (for example, preservatives, speeches, how to buffer the middle, correcting osmotic power and viscosity) may be suspected of thinking that it’s impossible to ignore the preparation.
6. Lykarsky preparations for muscular retention, with water breaks and to replace one and the same active substance (substance) in one and the most molar concentration and, for the day, one and the same concentration in other parts.
7. Medicinal preparations, such as water solutions for vigorizing in vigels and ingestions in a nebulizer, or in the capacity of nasal sprays, are intended for stagnation in vikors, for the reason, however, the same add-ons and concentration of one substance and, by day, one and the same additional speeches in different concentrations. Likarsky drugs can be a vengeance on additional additional speeches for thinking that the victorious drugs are innocent of the safety and / or efficiency of the drug.

In such a rank, the situation is known to know the need to carry out the latest news. And the visibility in the flow is seen behind the warehouse of additional speeches in the meantime, the applicant is obviously guilty of demonstrating by way of additional information. In general, there is a need for reason, as a guarantee of the therapeutic equivalence of a drug in the descriptions of the drug, there will be a statement of its quality to the normative documentation.

Okremі problems, wimagayut uvagi

In case of vikorystanna LZ, in case of їkh procurement for state contracts, there was a need for a mother to read the certificate, in which bullet it is written, which preparations are mutually interchangeable. Such a key word is an analogue of the Orange Book. But when it is formulated and when the general rules are established, it is necessary to have a lot of specific moments, except for the general description of the rules. Zupinimya on deyak private problems.
INN. Vidomo, scho the distribution of the replacement for the supply of medicinal products, we will be satisfied with the INN. The winyat is to become insulin and cyclosporine, for whom it is possible to work on trade names. It is necessary, however, that the INN (or the name of the INN) cannot serve as a single organizer.

Perche, preparations with a single speech (INN) can be derived from other characteristics (dosage, likarska form, method of storing), but in the zealous type of vyklyucha їх interdependence.
On the other hand, with the formal decision to make a pardon, OOZ samples are brought into the INN (and it is insured in the State Registry of the Russian Federation), for acids and submission (which is so obvious). For salts, ethers and other older types of the basic structure of the INN, they can be assigned only in the same category, as such are old and only one possible option. For example, assigned by the INN for salt - metamizol sodium. There are several reasons why the acid and metamizole are not consumed through the instability, but also in the case of metamizol. When taking a solution, you can use it in that, for one INN, you can really use it as a base, for example: ciprofloxacin (in front of it) and ciprofloxacin hydrochloride (acetic acid storage), hydrochloride structure). Yak mi meant food, drugs, to avenge different salts and efir, є pharmaceutically alternative. Fakhivtsi FDA such drugs do not imply therapeutically equivalent, but in some cases it is necessary to wait, in addition, in the zealous type of chemical modifications of different words, may be on the basis of changes in pinkness, crystallinity, stability, stability safe and effective drug.

Replacement of lykarskoy form. A radical change in lykarskoy form can give a negative effect in the face. For example, drugs for parenteral and oral administration are neither equivalent nor reciprocal. Moreover, the patient can be without evidence, and even needs one. It is possible to vimagatisya drug for rectal administration from looking around at those who are not patient. Preparations for muscular and systemic stagnation, to induce a stench to stagnate for the treatment of one pathology, may be absolutely effective (systemic effective).
Vіdomo, scho LZ, thаt ізні ways introduced, zagalі can get stuck behind the growing indicators. A textbook butt - fenoterol. The drug Berotek, rozchin or aerosol for inhalation - bronchodilator (for example, for the suppression of attacks bronchial asthma), A Partusten, tablets or a concentrate for infusions - tokolitikami (zapobіgannya front canopy).

Here it is also necessary to mean that the number of single forms in the package can also be used. For example, protizapl_dn_ tablets. One package contains 21 tablets. In іnshіy - 28 tablets, in others 7 - placebo. The FDA does not supply such drugs with therapeutic equivalents.

Pharmaceutically alternative preparations є powders for injections, for use in preparation, concentrated solutions for injections, for preparation for delivery, and ready solutions for delivery, as they do not need to take Such drugs, recognized by the FDA, are also not therapeutically equivalent.

Combined preparations. The problem is to replace a combined drug with a monopreparation, to replace the same common words and in quiet doses, as well as in a combination. For example, in the "Insights into the practice of looking at skarg on the basis of (inactivity) of the deputy, entrusted to the body, the special organization, the auction committee during the auctions in the field of health protection of the Federal Directorate, control of the distribution of the state deputy of the Federal Antimonopoly Service of Russia, Lipen, 2011) is meant, that “when the order is formed by the deputy of the lot for the purchase of antiviral drugs: combined and monopreparations, which are intended for the elimination of the need for combined in viglyadі 2 or 3 tablets are mutually interchangeable. " If you accept, well, it is permissible, then the decision of the problem can be specific, so that it is accepted for a skin preparation based on scientific evidence from the criteria of therapeutic equivalence.

Dura lex ...

Dіyalnіst, tied with LZ, regulated by law. Price incl. and purchase of medicinal products for state contracts. For example, according to the Federal Law No. 94-FZ (Part 3.1 of Art. 34), "Documentation of competitive bidding cannot be used to refer to service marks, registration names, patents, corsn_ models, promises of education, product selection and also vimogi to the goods, information, robots, services, as well as vimogi to pull along with themselves the interchange of the number of participants in the distribution of replacement. "

Ale, as I mean the fahivtsi of the company "Guarantor", "at the same time, it is necessary to remember, by means of changing the replacement є satisfying the needs of the deputy (Article 3 of the Law No. 94-FZ). They meant it in connection with the judge, the deputy must be guilty of setting up specific measures to the quality, to the functional characteristics (by the authorities) of the goods, to the size of the goods, packaging, so that the Federal Antimonopoly Service of the Zakhidno-Sibirsky District from 07.09.2010 at reference No. А03-2442 / 2010) ". And nutrition of the lawfulness of referring specific vimogs to the drug, to our thought, we can see the medical aspects that are displayed.

It seems, for example, that the situation occurred in 2010 with the purchase of the preparation zoledronic acid. When changing the replacement, the Ministry of Defense of the Russian Federation concretized the form and concentration of the drug in such a rank, which actually put on the drug of a specific virobnik - a solution for infusion of 5 mg / 100 ml. In this issue, the FAS has taken a decision about the damage, as it will intertwine the number of participants with the replacement, and the deputy has seen a definite attribution. The decision of the FAS was awarded to the Ministry of Defense in the Arbitration Court two institutes, but it was not in force. The list from the side of the LZ virobnik in this vypadnu was not necessary, so that after a while, liofilizate or a concentrate for preparing a bottle for infusions, as it is also available on the market, in this case it will be ready to replace not this way.

And the axis of іnsha, when it was built, is similar to the situation, for which in the bag it was taken as a solution. U 2010 r Kurgan region klinichna likarnya to take revenge on docetaxel. At the same time, supplementary vimogs are included in the auction documentation of boules: 1) concentrate for preparation of infusions for infusions 20 mg, filling a bottle of 24.4 mg / 0.61 ml in a set with a bottle holder of 1.98 ml in bottle No. 1; 2) concentrate for preparation of a bottle for infusions 80 mg, filling a bottle of 94.4 mg / 2.36 ml in a set with a bottle holder of 7.33 ml in bottle No. 1. This detail, by the day, was familiar with a specific drug - Taxotere. Moreover, the deputy chief didn’t pretend: according to the law No. 94-FZ, in the auction documentation he said not only the INN, but the first trade was named with the obligatory words “abo equivalent”. FAS protects the coal debris, fragments of the equivalent with such a form of release is actually not on the market, but the only preparations that could be replaced. However, when looking at the right in the arbitration court, the decision of the FAS was found to be unreasonable.
Absolutely unsuccessful turn, how to navigate fahivtsev, to the first glance, to be awesome. Ale naukove obgruntuvannya, on the yak, the court was in charge, we will attack. Quote: “... the decision of the OFAS in the Kurgan region was contested є it was illegal for the attacker: it was not insured by a special person, but it was stated in the documentation of the competitive bidding that the vial was liable to the amount of 24.4 mg / 0.61 ml. 4 mg / 2, 36 ml Only one way to get an effective dose of the drug, which is necessary for the deputy, who needs to take a dose of , vvazhaє, the surplus of the drug in the bottle is guaranteed by a dose of 20 mg, indicated on the label of the bottle. It is less similar to the vial as a result of adhesion to the product before the effective dosage, as it will be lower than necessary, as a result, if the drug is taken, the therapeutic effect will not be effective.

At the same time, there is a concentrate for preparing infusions of 80 mg. Napolyagu, which only takes a bottle, is supplied by the Applicant and instructions in the documentation of competitive bidding (24.4 mg / 0.61 ml and 94.4 mg / 2.36 ml), allowing you to preserve the exact dosage without additional vimiriv, at that hour like a bottle of іншого і Thus, the order in the documentation of the competitive bidding for the replacement of the bottle in the area is not enough for the purpose of ensuring the supply of the drug in that view, in which it is possible to prevent it from being effectively immobilized when the patients are caught by the patients who have not been seized from the shells. the wine of the contested decision. ".

Hover the butt once more on those who are able to navigate with the manifestation of some kind of backward skin control. Prior to the date of this problem, one can find an analogue of the Orange Book, in which one can be given, but one drug is not mutually beneficial, but the other is. Ale with a lot of intelligence, the robot is majestic. In fact, the price of science is based on evidence.

visnovok

When looking at the nutrition of the LZ's relationship, it follows that the LZ is created, but to take revenge on one and the same rank lykarska speech, not є therapeutically equivalent, but to mean, not reciprocally. Їх therapeutic equivalence must be brought to the skin preparation of the cutaneous virobnik. You can prove your guilt on the basis of scientific evidence, and the acceptance of a specific decision about replacing the drug is guilty of medical specifics and can be explained on the information presented in the case.

Once again, I will utterly respect the fact that when the food is not violated, LZ is released, incl. so that the State Pharmacopoeia, taking decisions, related to the interchange of drugs, becomes important.

literature

1. Biological availability of politicians: principle and problems. Add. Science. group BOOZ No. 536. - Geneva: WHO, 1975.
2. GARANT EXPERT: GARANT-Maximum (electronic resource).
3. Evaluation of bioequivalence of lykarsk workers. Methodical instructions... - M .: FDM NC ESMP, 2008.
4. Sheet of the Ministry of Economic Development of Russia, Ministry of Health and Social Development of the Russian Federation and the Federal Antimonopoly Service of the Russian Federation dated October 31, 2007 No. 16811-AP / D04, 8035-ВС і / ІА / 20555.
5. Tentsova A.I., Azhgikhina I.S. Lykarska form and therapeutic efficacy. - M .: Medicine, 1974 .-- 336 p.
6. Federal Law No. 61-FZ dated April 12, 2010 "About obig lykarskih zasobiv".
7. Federal Law No. 94-FZ dated 21 December 2005 to the Rock "On the distribution of replacements for the supply of goods, vikonannya robit, providing services for state and municipal needs."
8. Kholodov L.E., Yakovlev V.P. Clinical pharmacokinetics. - M .: Medicine, 1985 .-- 464 p.
9. Approved Drug Products with Therapeutic Equivalence Evaluations, 31st ed., FDA, 2011 rock.
10. CPMP / EWP / QWP / 1 401/98 Rev. 1 / Corr .: Guideline on the Investigation of Bioequivalence, EMA 2010.
11. Directive 2001/83 / EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use.
12. Generic Prescribing in Epilepsy. Is it Safe? P. Crawford, W. Hall, B. Chappell et al., Seizure 1996; 5: 1-5.
13. ICH Harmonized Tripartite Guideline: The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality M4Q (R1). - Geneva: ICH, 2002.
14. ICH Harmonized Tripartite Guideline: The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Safety. M4S (R2). - Geneva: ICH, 2002.
15. ICH Harmonized Tripartite Guideline: The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Efficacy. M4E (R1). - Geneva: ICH, 2002.
16. Joint Statement between The International Pharmaceutical Federation (FIP) and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA): Ensuring Quality and Safety of Medicinal Products to Protect the Patient. - Barcelona: FIP, IFPMA, 1999 ..
17. WHO Technical Report Series, No. 902, 2002. Annex 11: Guidance on the Selection of Comparator Pharmaceutical Products for Equivalence Assessment of Interchangeable Multisource (Generic) Products.
18. WHO Technical Report Series, No. 937, 2006. Annex 7: Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability.

Nutrition of interdependence of pharmaceutical preparations - the price of most confidential and folding nutrition of the pharmaceutical market. Between original and manufactured drugs (or generics), it is far from bezhmarny.

Peculiarities of patent acquisition of original drugs

Dyysno, the form of the original drug can be seen. Colossal cats, as they turn on the molecules of likarskoy speech for a joke, before the release of the word, on the market, retail monitoring of the unwelcoming effects and interconnection of fashion, through the chance to rock, if I go on patents in the future

Generic drug, which repairs the formulation often at once, "weed out" all the power, the vitality of the strength, the hour and the need, and the drug is original. I can skіlka zavladno vverdzhuvati, so the original will become the original, and the finished product will be created only by ourselves. The international non-patented name is to use analogous drugs for the patient, and the generic, as a rule, is less expensive, more addictive.

Vyrobniks of the original pharmaceutical brands seize their victories rights by means of new ways, in the first place for the benefit of patent law. The implementation of a patent claim for that molecule that lies in the basis of the political speech, transferring to the fence the idea of a term, the triviality of how to develop in the small lands, in the middle of the day

road to 20 rocks. It is necessary to vrahovuvati, as a cob of testing a new molecule and the moment the patent is filed, before the appearance of a lykarsky zasob on the market, it can take 10-15, or even more rocky. In such a rank, the virobnik of the original drug can be ordered in the middle up to 5 years to compensate for vitrates and the removal of divides from the original drug. Until the end of the term, as a rule, they try to find out about the peculiarities of patent legislation and loopholes in the new, to promote the term of the patent search. For example, in 1978, the main patent for the omeprazole molecule was revoked, repaired from the beginning of the 90s - for the magnesium sil of omeprazole, the way to get sick shlunkovo-intestinal tract in addition to the levorotatory isomer of omeprazole, the S-enantiomer of the magnesium salt of omeprazole in the form of trihydrate, a new crystalline form of omeprazole. Kozhen s perekhovannyh patents allowing the firm-robnik to struggle with probes vivedennya on the market of generics of omeprazole. The peculiarities of the implementation of patent law lie in the space between such understand, as a generic license (aka generic) and a copy of a license.

Generic drugs and copies

Generic drug to be called a lykarsky drug, the term of the patent will end. Apparently, the generic drug is not the sole authority of the pharmaceutical company, as it has broken up or has been licensed for its first sale.

copies- whole drug preparations, which are presented on the markets of the country with a weak or daily patent holder of chemical molecules - active ingredients in the drug industry.

According to the day, the statement of the copied drug from the generic drug is only the violation of the legal rules for the authorization of the drug (interchange of the patent holder's rights).

In the end bag, in the provinces with the developed patent holder, people are able to buy the original drug, and if the drugs in the generic line are not allowed to get their own place on the market.

In Russia, the situation is cheap. In the first place, it is necessary to provide a portion of generic drugs on the Russian pharmaceutical market (for the latest data, from 78 to 95%). The riches of the land of the great family are shaped by the following rank: in the USA - 12% of generics, in Japan - 30%, in Nimechchina - 35%, in France - 50%, in England - 55%, in Italy - 60%, in Canada - 64% ...

In a different way, the tradition of Radian medicine and the presence on the market of totally viable drugs, as well as drugs, vyroblenyh in the counties of the REV, provoked a deyakiy zsuv from the sprinkled brand names. So, Piracetam for Russian drugs - in the first place, the drug Nootropil is made; Co-trimoxazole is more vidomy under the name Biseptol; Renitek (enalaprilu maleat) have come to live for the name of the most successful Russian market generic - Enap; The original ciprofloxacin (Tsiprobay) is named Tsifran and Tsiprolet.

In such a rank, the specificity of the market is dictated by the origin of the original names, which is the origin of the sub-active vibration between the original and generics for the cinnamon of the last.

Thirdly, as if a country with a high level of sovereign protection in medicine, Russia is a generic drug that stinks dear. The price and designation of generics for the most popular sector of medicine - medicine is mentally bezel-less.

An active antigenericheskaya policy, which is carried out by the distributors of original leaks, has led to the fact that the term generic itself has added a taste of sophistication. This is due to the fact that the characteristics of the generic drug are different, lack of immunity, and the profile of safety is unspecified. Tim is an hour, for a lot of people who are not very efficient.

When evaluating generic drugs, mothers should be on the road.

Generic is to take revenge on the same active lykarska speech (substance), as well as the original (patenting) drug.
Generic is considered as an original drug by additional words (inactive ingredients, napovnuvachami, preservatives, barvniki etc.).
Considerations are promoted in the most technological process of generic production.

Pharmaceutical, biological and therapeutic equivalence

Most often, the term “generic” is not always replaced by the term “equivalent lykarska speech”. Vlasne, a similar term є meaningless, as it is not a clear understanding of the "equivalence of lykarsky speeches." There are advances in the type of equivalence: pharmaceutical, biological and therapeutic. In the countries of the European Union and in the United States, the definitions of pharmaceutical equivalence of lykarsky rechovins are vicious.

The main criteria for bioequivalence are the level and speed of absorption of liquor, the hour of reaching the maximum concentration in the blood and the meaning, the nature of the drug in the tissues and the tissues of the body, the type and quantity of the drug).

I also see pharmaceutical bioequivalence, like looking out, like being introduced with a generic drug in the warehouse and in the form of an original drug.

bioequivalence assessment

Bioequivalence will be established by certified pharmacological centers in pre-admission for the participation of healthy volunteers.

Victory of tribute from bioequivalence

Before the end of the bioequivalence, I will be sure of the sufficient efficiency and safety of the "yak generic", due to the quality of the original licars.

Reasons for different bioequivalence

Ideas in the warehouse and structures of substances for the preparation of the preparation (houses, isomers, crystalline form, etc.)
Visibility in the warehouse of ancillary chapters, vicarious for generic marketing
Evidence in technology for production of licars' forms

Div. also

literature

Methodical recommendations for the implementation of good clinical dosages of bioequivalence of drug preparations. M., Ministry of Health of the Russian Federation, 2001.- 24 p.
A.P. Mushkovskikh. Recommendations of the WHO in the field of validation of the equivalence of manufactured drugs. Pharmateca, 1996. © 3.S. 3-7.
Hussain AS, et al. The Biopharmaceutics Classification System: Highlights of the FDA's Draft Guidance Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration.
Mills D (2005). Regulatory Agencies Do Not Require Clinical Trials To Be Expensive International Biopharmaceutical Association: IBPA Publications.
FDA CDER Office of Generic Drugs - further U.S. information on bioequivalence testing and generic drugs

posilannya

Birkett D (2003). Generics - equal or not? Aust Presc 26 (4): 85-7.
Food and Drug Administration (2003). Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations. Rockville (MD): FDA.
EMEA, CPMP, Note for Guidance on the investigation of Bioavailability and Bioequivalence, London, July 2001 CPMP / EWP / QWP / 1401/98.

Wikimedia Foundation. 2010 rock.

Pharmaceutical equivalence

Drugs that are pharmaceutically equivalent, as it smelt to replace the same active substances in the same quantity and in the same drug form, which are similar to the same strengths of the same standard and the same Often, unaffected by the same change of speech, a generic drug is produced from the original one behind the warehouse of additional speech

Warehouse of original Vigamox preparation and generic Moxin in a pererakhunka for 5 ml retail

Vigamox (28)
Moxitsin (29)

Chinne speech oxifloxacin hydrochloride 0.02725 g moxifloxacin hydrochloride 0.02725 g

Benzalkonium chloride preservative

Інші additional speech sodium chloride sodium chloride

boric acid

hydrochloric acid і / аbo sodium hydroxide (for pH adjustment)

water for ін'єкцій

Before the warehouse of generic moxifloxacin hydrochloride includes a preservative, the original Vigamox preparation cannot be revenged on the preservative.

bioequivalence

Two drugs vvazayutsya bioequivalent, as the stench є pharmaceutically equivalent, may be the same bioavailability and given in the same dosage є take care, without having proper efficiency. Due to the bioavailability, there is a rise in fluidity and a part of the moisture content of the active ingredient or the active component of the drug, as it repairs the action at the point of application.

By day, bioequivalence - at the same time the level of fluidity and level of acceptance of the original and generic in the same doses in terms of concentration in births and tissues to the body. The reliability of the results in the approximate dosage of bioequivalence is quite abundant in what can be found in the prior art (GMP - proper key practice) І maє but independent, large-centered, randomized, controllable, trivial.

Yakshcho generic permissions until stashed in the other regions, must be restructured in the Russian Federation for a simplified scheme (without a validity of bioequivalence). In such a rank, during the restoration of foreign generics in the Russian Federation, in the meaning of the world doviryamo dossi, which is served by pharmaceutical companies. Such "trust" in a number of vipadks is expensive for patients, so generics for their pharmacokinetic powers may not be considered the original drug. On the application of the control conversion of bioequivalence of generics to the original clarithromycin C.N. Nightingale and invented the original drug clarithromycin with 40 copies of bioequivalence, according to the standards of the American Pharmacopoeia. Previously, it has shown that 70% of generics are significantly higher than the original drug, which is critical for their development. 80% of generics are derived from the original as a small ear of cob in one single product. There are a lot of houses, which do not seem to be as big as the earliest, in most cases it is more, less in the originals. The “short” generic їkh had 2%, the “girshom” - 32%. The emergence of the houses caused the turn of side reactions.

Ophthalmologists face a similar situation. Congdon N.G. Inspiration (2001) based on the results of a randomized sub-baseline dormant drug, a drug was introduced into the subdivision of the conjunctiva,