Development Of Generic Product And Approval

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Generally, an ANDA sponsor of the topical dermatological product has to undergo multiple review cycles with the FDA before the product gets approved and the sponsor has to wait for a longer time mostly. Even though the ICH CTD, ICH Q8 describes the generation of product development report, it is not still clear to ANDA sponsors how this actually applies. As a result, more internal meetings and discussions between the sponsors and the FDA delays the product approval. One of the ways to overcome these challenges is to have a product development report with verified and justified specifications based on the QbD efforts which can help the Office of Generic Drugs (OGD) to be efficient in understanding the developed generic product and approval…show more content…
The foremost criteria in developing a generic topical dermatological product is to meet the pharmaceutical and therapeutic equivalency of the RLD. A therapeutic equivalence is the one which has the same clinical effect and safety profile as given in the label of the RLD and a pharmaceutical equivalence is the one which contains identical amount of same active ingredient corresponding to the same route of administration in the same dosage form with similar mechanism of release and similar rate and extent of the absorption of the RLD. The current paradigm to get an approval by an ANDA sponsor is by proving the therapeutic equivalence to the RLD by testing whereas the proposed QbD approach requires the sponsors to meet the equivalence on the basis of defined design targets. More specifically, a well-defined rational approach behind each testing is required for proving the pharmaceutical equivalence and bioequivalence [18]. When talking about the design of equivalence of a generic dermatological topical product, the criteria for Q1 and Q2. Additionally, in some cases, the Q3 criteria has to be satisfied in addition to Q1 and Q2 Topical solutions can be stated as an example for Q3. The Q1, Q2 and Q3 may not be a feasible option if the patent of the RLD is considerably protected. In such cases, the generic manufacturer may be in a position to look for alternate
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