This episode discusses the challenge of balancing rapid innovation with rigorous safety standards in modern drug development. Conversation on risk management, ethical considerations, and regulatory requirements are presented with detailed examples. Discussions start with how a drug process happens and why pre-clinical phases of research exist. The importance of the FDA and ICH guidelines is highlighted.
Conversations on the need for innovation versus the ethical need to make drugs and medical technologies safe. There is a discussion on models like sarcoma and the importance of pre-clinical testing. Mention is also made on designing for degradation, or the "cradle to grave" method of drug design.
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