PharmPK Discussion - Sample Size for intraindividual bioequivalence

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On 29 Apr 1998 at 10:41:07, "PharmaContract - dbrandt" (dbrandt.at.pharmacontract.ch) sent the message


The FDA has new draft guidelines (12/97) for bioequivalence
studies. Can anybody tell me the method of sample size calculation
for intraindividual bioequivalence or is there a publication which
describes this method.

Derek Brandt
--
Swiss Pharma Contract
Derek K. Brandt
PO-BOX
4002 Basel Switzerland
e-mail: dbrandt.aaa.pharmacontract.ch

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On 30 Apr 1998 at 11:52:24, Carlos Ramos Mundo (cramos.aaa.cueyatl.uam.mx) sent the message


Greetings from Mexico:

You can try "sample size calculations". Mace (1974).  It is a book
oriented to statisticians but the principles to sample size calculations
apply to all cases.  It is beatiful  book.

Hope this is useful.

Carlos Ramos Mundo MS
E-mail: cramos.at.cueyatl.uam.mx
ph/fax: (525)6188739

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On 30 Apr 1998 at 11:52:43, "Dr. W. Webster" (webstew.aaa.mail.firn.edu) sent the message


You may find the following artice interesting:  Copies can not be provided

Jones B, Jarvis P, et al   Trials to assess equivalence: the importance of
rigorous methods. BMJ 1996;313:36-9

WW

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