BA/BE Policies and Requirements

  • Requirements for investigational new drug application
  • Procedures for determining BA/BE of drug products
  • Requirements for submission of BA/BE data
  • Criteria for waiver of evidence of in vivo BA/BE measurements
  • Differences in the in vitro and in vivo pharmacokinetic profiles: Examination of current bioequivalence
  • Bioequivalence recommendations for specific products

Related Conference of BA/BE Policies and Requirements

BA/BE Policies and Requirements Conference Speakers