Q: What level of GMP need to be followed for clinical trial materials (for a generic ANDA) intended for animal studies if the drug is already in the market?

—Srinivas Yandrapu, Manager-Development Quality, Dr. Reddy’s labs

A: The quality standard for animal health clinical trial material (CTM) is the same as that for human health pharmaceutical products. CTM for the generic product should be manufactured to GMP. All raw materials must be release tested against their specification and the analytical methods used for finished product release must be fully validated. The batch should be at least 10% of the intended commercial batch size and be made with the same or similar equipment to what will be used for commercial manufacture. If studies will be conducted that include the innovator’s product as a comparator this can be purchased commercially.

—Rich Myer, Argenta Ltd.

A: GLP safety/toxicology is needed for the generic drugs undergoing clinical development, especially, for different therapeutic indication. Otherwise, the animal tox should not be needed if designed for the same therapeutic indication as the brand drug.

—Dr. Shaukat Ali, BASF