• 00:51 – Meranda and Ed discuss the Regulatory Odd Couple blog series and constructing the CTD Module 3  
• 11:54 – Ed explains the importance of building the Quality Overall Summary (QOS) and the different starting points for drug process development  
• 19:45 – Ed and Meranda talk about characterization, the process of manufacturing drug substances/products and the importance of excipients  
• 37:44 – Ed expounds on the analytical aspect of API and regulatory drug development  
• 46:55 – Ed and Meranda share their thoughts on the process of packaging drug substances  
• 49:09 – Ed and Meranda discuss the role that stability plays in development methods  
• 53:42 – P2 Pharmaceutical Development  

“If anyone’s listening and not familiar with the drug development process, the one area that’s most important is the FDA guidance.” 

“Characterization is, in my mind, one of the fundamentals of a product and a process and a program. If you don’t know what you’re dealing with to start, it’s hard to catalog it, make it consistently and answer questions about it.”

“This is probably, in some folks’ minds, the most important. It’s the manufacturing of the drug substance and the drug product. If you don’t have a process, you don’t have a product.” 

“There are a few caveats to excipients. One of the things you’ll want to recognize and a question that might come up is ‘are they of human or animal origin?’ And the other big thing is ‘are they novel?’” 

“Any changes to anything in the program – process-wise or control-wise – late in the game could be a problem because you’re gonna have to generate additional data. There’s an unknown there. What does that change mean?” 

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Odd Couple Series