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Advancing Development of Generic OINDPs through In Vitro Testing

May 04, 2017 According to a 2007 report Measuring Trends in the Development of New Drugs: Time, Costs, Risks and Returns by J.A. DiMasi, companies spend an estimated $1.2-$1.3 billion on research and development for each approved drug due to the increasing complexity of the research and development process—particularly clinical trials. That’s a $500 million

Case Studies of Foreign Particulate Analysis

Authors & ContributorsDavid Exline January 23, 2019 Topics covered include analytical techniques and methods suitable for API particle sizing and in vitro bioequivalence for nasal drug products as well as preparation methods and a review of case studies. The presentation also provides FDA guidance related to particle size distribution (PSD) and regulatory considerations for PSD