Evaluation of herbal medicinal products : perspectives on quality, safety, and efficacy /Publisher: Chicago : Pharmaceutical Press,
Date: 2009. This title can be found in 1 Iowa libraries.
Guidance for industry tropical disease priority review vouchers.Format: [electronic resource] :
Publisher: Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ;
Date: [2008] This title can be found in 2 Iowa libraries.
Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticalsFormat: [electronic resource].
Publisher: [Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,
Date: 2008] This title can be found in 2 Iowa libraries.
S2(R1) genotoxicity testing and data interpretation for pharmaceuticals intended for human useFormat: [electronic resource].
Publisher: [Rockville, MD? : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,
Date: 2008] This title can be found in 1 Iowa libraries.
Guidance for industry process validation, general principles and practices.Format: [electronic resource] :
Publisher: Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ;
Date: [2008] This title can be found in 2 Iowa libraries.
Guidance for industry CGMP for phase 1 investigational drugs.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [2008] This title can be found in 1 Iowa libraries.
Drug testing in vitro : breakthroughs and trends in cell culture technology /Publisher: Weinheim : Wiley-VCH,
Date: [2007] This title can be found in 1 Iowa libraries.
Prescription drugs FDA guidance and regulations related to data on elderly persons in clinical drug trials.Format: [electronic resource] :
Author: Crosse, Marcia.
Publisher: Washington, DC : U.S. Govt. Accountability Office,
Date: [2007] This title can be found in 2 Iowa libraries.
Q4B, annex 3, evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for particulate contamination, sub-visible particlesFormat: [electronic resource] /
Publisher: [Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,
Date: 2007] This title can be found in 2 Iowa libraries.
Guidance for industry drug-induced liver injury, premarketing clinical evaluation.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [2007] This title can be found in 2 Iowa libraries.
Die Pille & ich : ein Mann im Selbstversuch /Author: Witchalls, Clint,
Publisher: Reinbek bei Hamburg : Rowohlt-Taschenbuch-Verlag,
Date: 2007. This title can be found in 1 Iowa libraries.
Guidance for industry S8 immunotoxicity studies for human pharmaceuticals.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [2006] This title can be found in 2 Iowa libraries.
Statistical monitoring of clinical trials : a unified approach /Author: Proschan, Michael A.
Publisher: New York, NY : Springer,
Date: c2006. This title can be found in 2 Iowa libraries.
Fundamentals of early clinical drug development : from synthesis design to formulation /Publisher: Hoboken, N.J. : Wiley-Interscience,
Date: [2006] This title can be found in 1 Iowa libraries.
Guidance for industry S7B nonclinical evaluation of the potential for delayed ventricular repolarization (QT Interval Prolongation) by human pharmaceuticals.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [2005] This title can be found in 2 Iowa libraries.
Guidance for industry E2B(M), data elements for transmission of individual case study reports, questions and answers.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [2005] This title can be found in 2 Iowa libraries.
Guidance for industry E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [2005] This title can be found in 2 Iowa libraries.
Guidance for industry estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,
Date: [2005] This title can be found in 2 Iowa libraries.
New directionsFormat: [videorecording] /
Publisher: Princeton, NJ : Films for the Humanities & Sciences,
Date: c2005. This title can be found in 1 Iowa libraries.
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