Clinical Research and Regulatory Affairs, Volume 28, Issue 4 (2011)

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Clinical Research and Regulatory Affairs, Volume 28, Issue 4 (2011)

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Commentary

Article
Renovation of the new medicine regulatory process
Stanley T. Crooke MD, PhD
Pages: 81-86
Published online: 30 Nov 2011
First Page PreviewforRenovation of the new medicine regulatory process | Full Text | References | PDF (562.1 KB)
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Research Articles

Article
Regulatory recommendations for clopidogrel: Focus on validation of a reliable bioanalytical method and its application to a bioequivalence study
Surajit Dey, Kirti Kandhwal, Shabana Nazarudheen, Onkar Singh, Subhra Kanti Mukherjee, Sanjeev Mishra, Simrit Reyar, Arshad H. Khuroo & Tausif Monif
Pages: 87-95
Published online: 29 Oct 2011
AbstractforRegulatory recommendations for clopidogrel: Focus on validation of a reliable bioanalytical method and its application to a bioequivalence study | Full Text | References | PDF (739 KB)
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Article
International regulatory review: Israel
Sandy Weinberg & Qiu Fang
Pages: 96-99
Published online: 30 Nov 2011
AbstractforInternational regulatory review: Israel | Full Text | References | PDF (534.7 KB)
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Article
Controlling type I errors for two-stage bioequivalence study designs
Anders Fuglsang
Pages: 100-105
Published online: 30 Nov 2011
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