Opportunity to Join FDA and CRCG Workshop on Bioequivalence Frameworks for Inhalation Drug Products

FDA shared on LinkedIn:

“Join FDA and CRCG on October 14-15 for the workshop on ‘Advancing Bioequivalence Frameworks for Inhalation Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods.’

Topics

• Developing and using in vitro methods including, realistic APSD, dissolution, and particle morphology
• Current expectations and potential alternatives to charcoal block in vivo PK studies
• When PK study biowaivers may be applicable for additional strengths
• Opportunities to streamline generic development programs
• Waiver requests and formulation sameness considerations for bioequivalence approaches.”

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