Q. Explain In Detail About Generic Drug Development Process ?
Ans :-
• Generic Drug Development Process :-
1) Drug Candidate Selection :-
In this phase organization setup a dedicated expert team to select multiple solution for a problem identify by a market survey.
This phase converted the broad selection of potential drug candidates a rigorous session of brain storming are conducted to reach narrow down the list . A team decides which drug candidates should be selected to proceed into the preliminary assessment phase.
2) Candidate Drug Screening :-
In This Phase Drug candidates selected the earlier phase is carefully screened to roughly assess the potential drug candidates. The simple strategy followed to accept best and eliminate poor this only covers marketing potential , the production possibilities R and D and registration strategy as well as purchasing strategy.
3) Concept Development :-
In This screened candidate drug is translated into the product concept it include detail version of product idea also include function , features of a product and usually accompanied by set of specification , an analysis of connective product and economic justification of the product.
4) System Level Design:-
It include the definition of the product composition and the division of the product into subsystem and components final formulation scheme also defined output of phase is a product layout with functional specifications of each product components and preliminary flow to final product.
5) Detail Design :-
Include complete specification of the in materials and limits of all the components including the product and the identification of all the components in the product and the identification of all the probable suppliers also a process plan is established with control of documentation for the product.
6) Concept testing -
It is laboratory development of generic product this phase starts with experimental and accelerated stability work based on laboratory scale including bioequivalent study and development of primary packaging the scale up from laboratory to a semi industrial scale is done.
7) Business analysis -
In this phase every organization fixes landmarks and milestones of the product development process and time required for completion. Also in this phase impacts of delays and time of product arrival in the market are analyzed carefully.
8) Development of technology -
It include the transfer to the industry measure and preparation of registration, documentation is done. Also clinical studies, toxicological effects, bioequivalent studies and complete stability studies are studied
9) Registration -
It is phase of filing of registration dossiers at regulatory authorities. It finishes when the product is registered and registration, documentation and marketing authorization is obtained.
10) Development pf prototype -
Development, testing, modification, in prototype and pilot production and it is also called ramp up.
11) Launch -
All final pre launch activities such as ordering of materials, production of launch stock, ordering of raw material, packaging etc. and launch of product on selected market
The overlapping of different activities from different phases described above reduces the time to launch the generic product into the market.
STAGES OF GENERIC DRUG DEVELOPMENT -
1) Predevelopment stage -
Involves collecting, evaluating data and information related to drug such as physiochemical, critical quality attributes before implementing any development activities.
Also trade related information on the patent or or any market exclusively relating to the innovators product is shared.
2) Second development stage -
Through characterization of innovators product followed by compatibility studies, methods, manufacturing process selection etc. It should result in a model generic product with invitro similarity with the innovators product for pilot biotech.
3) Third development stage -
Pilot biotech of generic product is obtained and an in vivo equivalent test is conducted in accordance with the GCP to assure that the generic product is therapeutically equivalent to the innovators product.
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