US FDA/EMA harmonization of their bioanalytical guidance/guideline and activities of the Global Bioanalytical Consortium.
The 2011 annual conference of the American Association of Pharmaceutical Scientists, held in Washington DC, USA, hosted a roundtable entitled: 'Update of the US FDA/European Medicines Agency (EMA) harmonization of their bioanalytical guidance - Global Bioanalytical Consortium activity and impact on small and large molecules.' The roundtable was initiated with a presentation from CT Viswanathan on the history of the revision of the FDA guideline on bioanalytical method validation. It was followed by a presentation by Jan Welink who presented an update on the final European Medicines Agency guideline on bioanalytical method validation with relevance to ongoing harmonization efforts. The final presentation was by Fabio Garofolo on the progress of the Global Bioanalytical Consortium harmonization teams for small and large molecules. Brian Booth and Sam Haidar of the FDA updated the audience on the status of the revision of the FDA bioanalytical guidance. The roundtable was moderated by Stephen Lowes.
Algorithme Pharma Inc., Laval (Montreal), QC, Canada. fgarofolo@algopharm.com
Fabio
F
Garofolo
Josée
J
Michon
Virginie
V
Leclaire
Brian
B
Booth
Stephen
S
Lowes
C T
CT
Viswanathan
Jan
J
Welink
Sam
S
Haidar
Leonardo de Souza
Lde S
Teixeira
Daniel
D
Tang
Binodh
B
Desilva
D017408:Guidelines as Topic; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations