β Scribed by Kamal K. Midha; Vinod P. Shah; Gur Jai Pal Singh; Rabi Patnaik
No coin nor oath required. For personal study only.
This is a summary report of the International Pharmaceutical Federation/ Board of Pharmaceutical Sciences (FIP/BPS) international conference, Bio-International 2005, which was held October 24-26, 2005 at the Royal Pharmaceutical Society, in London, UK. Bioequivalence (BE) issues related to multisource locally delivered topical dosage forms, oral inhalation drug products, highly variable drug products (HVDP), and endogenously occurring drugs were discussed. The conference also focused on alternate approaches to assess BE for some of these drug products. Pharmacokinetic (PK) approaches like, dermatopharmacokinetics (DPK) for dermatological topical dosage forms, scaled average BE (s-ABE) where within-subject variability is considered for estimation of 90% confidence intervals to document BE for highly variable drugs (HVD) were recommended. In addition, issues and difficulties related to the BE assessment of oral inhalation products, role, and appropriateness of metabolites in BE assessment, importance of base line correction in BE assessment of endogenously occurring drugs, and waiver of BE study requirements for certain drugs based on a Biopharmaceutics Classification System (BCS), were also discussed.
π SIMILAR VOLUMES
## Abstract There are many ways to classify ectodermal dysplasia syndromes. Clinicians in practice use a list of syndromes from which to choose a potential diagnosis, paging through a volume, such as FreireβMaia and Pinheiro's corpus, matching their patient's findings to listed syndromes. Medical r