Generic Pharmaceuticals: Development, Testing, and Regulation

In this episode of Chasing Compliance, Jamie talks with Brandi Quinlin and Rebecca Lynch about generic drugs. The discussion ranges from what a generic drug is to how generic drugs are made, tested, and approved. Brandi and Rebecca also share their knowledge of drug formulation with some “delicious” analogies. Who knew chocolate chip cookies could reveal so much about generics? Lastly, they discuss regulatory requirement for getting a generic to market.

Brandi Quinlin holds a master’s degree in regulatory affairs and brings years of experience in pharmaceutical development, generic development, pharmaceutical testing, and regulatory compliance. Rebecca Lynch is one of Global’s resident generic drug experts. She has a background in analytical method development and 25 years of experience in the generic pharmaceutical industry.

1:30 – What is a drug product?

4:30 – Active vs. inactive ingredients, what is the difference?

5:30 – What are key differences between immediate release and extended release and drug formulations?

12:00 – How do manufacturers select a compound/drug testing strategy?

17:40 – How do generic manufactures select a formulation and form factor?

23:30 – Are generics exact copies?

26:30 – Do generics need to go through clinical trials?

31:00 – What is the process for bringing a generic to market and what is required from a regulatory perspective?

37:30 – How does the FDA evaluate the formulations of generics?

45:40 – Favorite Friday Nights