Note sull'episodio
This episode focuses on understanding the expectations of the FDA during the regulatory review process for new drug applications. We explore the key data points and presentation formats that meet these expectations, highlighting the importance of clearly demonstrating the drug's safety and effectiveness. We delve into the concepts of pharmacokinetics (PK) and pharmacodynamics (PD) and how they provide crucial information about the drug's behavior in the body. We discuss the importance of bioanalytical method validation to ensure the accuracy and precision of drug concentration measurements. Join us as we demystify the FDA review process and provide insights into what regulators look for in a successful submission.
This episode further explores the FDA's focus on Chemistry, Manufacturing, and Controls (CMC) information, emphasizing the impor ...