Bioequivalence and Bioavailability Forum

Dear Helmut and El Maestro,

Over 10 years ago the SFSTP (Société Française des Sciences et Techniques Pharmaceutiques) published two papers on bioanalytical method validation, in which they discussed linearity issues and weighting. The first paper presented theory, the second paper was a practical example (in which they concluded that for that method, weighting should be 1/X^1.754 ).

The papers are so complex that I never saw anybody use them, and they were issued before the FDA guidance (even before the draft 1998 guidance), so they are very far from current recommendations. But they are worth having a look at for some aspects of the discussion.

They were originally published in French (I give the reference for the few French-speaking readers of this forum ):

Méthodes chromatographiques de dosage dans les milieux biologiques: stratégie de validation. Rapport d'une commission SFSTP.
E. Chapuzet, N. Mercier, et al.
S.T.P. Pharma Pratiques 7(3) 169-194 1997

Méthodes chromatographiques de dosage dans les milieux biologiques. Exemple d'application de la stratégie de validation. Rapport d'une commission SFSTP
E. Chapuzet, N. Mercier, et al.
S.T.P. Pharma Pratiques 8(2) 81-107 1998

They were later re-published in English:

New strategy for the validation of chromatographic bioanalytical methods
SFSTP commission: E. Chapuzet, N. Mercier
S.T.P. Pharma Pratiques 10(1) 21-38 2000

Example of application of the new strategy proposed for the validation of chromatographic bioanalytical methods
SFSTP commission: E. Chapuzet, N. Mercier
S.T.P. Pharma Pratiques 10(2) 79-101 2000

Regards
Ohlbe