E-drug: Antidiarrhoeals (cont'd)
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I remember a hilarious incident in drug registration many years ago
when the French manufacturer of such a preparation applied for
registration in Holland. His "key" trial was one where the consistency,
form, and colour of the faeces were observed and noted down on
analogous scales. The trial was done in France where toilet bowls
universally are of the "flush-down" type where you cannot observe
those qualities of what one has produced. When one of the members of
the registration committee drily suggested that these data were
therefore probably faked, the manufacturer immediately withdrew his
application. Actually such trials are quite difficult and defining
parameters is not so easy.
Leo Offerhaus MD PhD
Koedijklaan 1a, NL-1406KW Bussum, the Netherlands
Phone +31-35-6923288 Fax +31-35-6923290
E-mail: LO@EURONET.NL or CompuServe 71530,15
EJCP Only: POB 75552, NL-1070AN Amsterdam
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