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FDA Publications of Interest

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International Bioequivalence Standards: A New Era
by Gordon Amidon, Lawrence Lesko, Kaml Midha, Vinod Shah and John Hilfinger
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Membrane Transporters As Drug Targets (Pharmaceutical Biotechnology, V. 12)
by Gordon L. Amidon(Editor). Hardcover (January 2000)
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Chemical Stability of Pharmaceuticals : A Handbook for Pharmacists
by Kenneth A. Connors, et al. Paperback (September 1986)
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Transport Processes in Pharmaceutical Systems (Drugs and the Pharmaceutical Sciences, V. 102)
by Gordon L. Amidon(Editor), et al. Hardcover (June 2000)
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Peptide-Based Drug Design : Controlling Transport and Metabolism (Professional Reference Book)
by Michael D. Taylor, Gordon L. Amidon (Editor). Hardcover (December 1994)
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Pharmacokinetic Analysis : A Practical Approach
by Peter I. D. Lee, et al. Hardcover (July 1996)
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Mechanisms of Drug Interactions (Handbook of Experimental Pharmacology, Vol 122)
by Gordon L. Amidon(Editor), et al. Hardcover (June 1996)
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Below are titles to a number of guidance documents that are relevant to services performed at TSRL, Inc.:

Dissolution Testing of Immediate Release Solid Oral Dosage Forms (Issued
8/1997) www.fda.gov/cder/guidance/1713bp1.pdf

Extended Release Oral Dosage Forms: Development, Evaluation, and
Application of In Vitro/In Vivo Correlations (Issued 9/1997)
www.fda.gov/cder/guidance/1306fnl.pdf

Waiver of In Vivo Bioavailability and Bioequivalence Studies for
Immediate Release Solid Oral Dosage Forms Containing Certain Active
Moieties/Active Ingredients Based on a Biopharmaceutics Classification
System (Issued 1/1999)
www.fda.gov/cder/guidance/3618fnl.pdf

FDA guidance website: www.fda.gov/cder/guidance/guidance.htm