The first step in the research and development of generic drugs is to determine reference preparations, which include original drugs and internationally recognized similar drugs.
Selection of reference preparation
Among them, the original drug refers to the first drug approved for marketing at home and abroad and proved by complete clinical data, effectiveness and safety.
RLD: It is the reference preparation designated by FDA, that is, the original research drug, whether it is listed or terminated.
In order to avoid the shortage of drugs, as long as the original research institute does not withdraw drugs from the market because of safety and effectiveness, generic drugs can continue to apply for RLD, so where can we find RLD in the market?
RS reference drug is a reference substance used in the study of bioequivalence (BE) of generic drugs in vivo. Of course, RLD is still on the market, so scientists usually choose the maximum dose specification, and small specifications can BE exempted from BE through in vitro research (dissolution comparison).
If when RLD exits the market, FDA will choose RS among generic drugs, and it will choose equivalent and sales dozen, including all specifications as much as possible.
The only purpose of RS is to compare with generic drugs and conduct BE test to determine bioequivalence in vivo.
The equivalence of generic drugs must also be compared with RLD in other aspects, such as pharmacies, products, accessories, prescriptions and even instructions.
Reference product
If the original research institute withdraws from the market, we need to check the reasons for its withdrawal first. If there is a problem with safety and effectiveness, and the application materials have been reported, we still have to accept the planting. When we want to make generic drugs, we must pay attention to the progress of the original drugs.
Inquiring about reference preparations is the first step in the research and development of generic drugs, which is difficult at first, and even more difficult at the middle end. First, mainly determine the reference preparation. The database can be used to query the data of reference preparations, and the reference preparations of generic drugs can be queried and determined under the consistency evaluation, such as reference preparation catalogue, reference preparation filing, American orange book, etc.
In the catalogue of general reference preparations, the reference preparations can be determined by the conditional selection of information sources (the first to forty-four batches).
In the American orange book, you can choose whether it is a reference preparation or not, and you can also determine the reference preparation according to the reference standard preparation (RS).
Generally speaking, consulting reference preparations is the first step in the development of generic drugs. Only by choosing the right one can the following research on prescription technology, quality, stability and drug toxicology be carried out. Everything is difficult at the beginning, and the next step is even more difficult. If you do the first step, you have to overturn it and do it again. Therefore, it is very important to select the reference preparation.
In addition to researching and querying reference preparations in the database, it can also help drug research and project establishment, research and query domestic and international marketing data, clinical data, patent data and sales data, and help drug research and development.