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Volume 10, Issue 4

Clinical Research and Regulatory Affairs

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Clinical Research and Regulatory Affairs, Volume 10, Issue 4 (1993)

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Clinical Research and Regulatory Affairs, Volume 10, Issue 4 (1993)

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Research Article

Article

International Harmonization of Regulatory Bioequivalence Requirements

V. W. Steinijans & D. Hauschke

Pages: 203-220

Published online: 28 Sep 2008

AbstractforInternational Harmonization of Regulatory Bioequivalence Requirements | References | PDF (940.2 KB)

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Article

Outlier Tests and Chemical Assays

Sanford Bolton

Pages: 221-232

Published online: 28 Sep 2008

First Page PreviewforOutlier Tests and Chemical Assays | References | PDF (565.4 KB)

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Article

Bayesian Estimation and Population Pharmacokinetic Parameters of High Dose Methotrexate in Osteosarcoma

C. Sabot, J. Debord, B. Roullet, H. Lotfi, G. Lachátre, L. Merle & J. P. Olivier

Pages: 233-241

Published online: 28 Sep 2008

AbstractforBayesian Estimation and Population Pharmacokinetic Parameters of High Dose Methotrexate in Osteosarcoma | References | PDF (359.3 KB)

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Article

Phase I Studies and Database Consultation

Hans-Peter Graf & Dennis Cole

Pages: 243-252

Published online: 28 Sep 2008

AbstractforPhase I Studies and Database Consultation | References | PDF (490.1 KB)

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Article

A Response to Recent Gmp-Validation Interpretations

Robert A. Nash

Pages: 253-264

Published online: 28 Sep 2008

First Page PreviewforA Response to Recent Gmp-Validation Interpretations | References | PDF (538.6 KB)

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Book Review

Understanding Biotechnology Law: Protection, Licensing and Intellectual Property Policies

Steven R. Englund

Pages: 265-267

Published online: 28 Sep 2008

First Page PreviewforUnderstanding Biotechnology Law: Protection, Licensing and Intellectual Property Policies | PDF (139.5 KB)

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Clinical Research and Regulatory Affairs (Vol.10, Iss.4, 1993)

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