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Has anyone out there in PK-land ever done an individual BE study? If
so, can you give me a call.
Thanks,
pete bonate
Peter L. Bonate, PhD
Genzyme Corporation
Senior Director, Pharmacokinetics
4545 Horizon Hill Blvd
San Antonio, TX 78229 USA
peter.bonate.-a-.genzyme.com
phone: 210-949-8662
fax: 210-949-8219
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Dear Dr. Peter
we have done a replicate crossover designed BE study. You can find
additional info about this issue in the FDA guideline:
Guidance for indudtry :Statistical Approaches to Establishing
Bioequivalence,
Hope this helps.
Isra' Admour, M.Sc Pharm
Regualtory Affairs Director
International Pharmaceutical Research Center (IPRC)
www.iprc.com.jo
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