Advancing Development of Generic OINDPs through In Vitro Testing

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 increase from 2000.

This webinar recording addresses how novel analytical methods, along with scientific and regulatory expertise, can help cut the time and costs associated with getting generic orally inhaled and nasal drug products (OINDP) to market.

Highlighted Topics Covered

  • FDA guidance that control various aspects of both chemistry, manufacturing and controls (CMC) and bioactivity/bioequivalence requirements.
  • Regulatory pathways for generic OINDP products, including specific issues related to the pharmaceutical medical device and biotechnology industries.
  • Current trends in in vitro novel analytical method development.
  • FDA Critical Path Initiative for bioequivalence of nasal spray suspensions.
  • Nonconformance issues or deviations of drug product during manufacturing via pharmaceutical forensics.