Welcome to the Kids' Library!

Addendum to ICH S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals.

[Rockville, Md.? : U.S. Dept. of Health and Human Services, Food and Drug Administration, 2009] 2009

Advances in collating and using trial data

London, England : Future Science Ltd, 2014. 2014

CDC trials of daily oral tenofovir for preventing HIV infection phase II and III clinical trials in

[Atlanta, Ga.] : Centers for Disease Control and Prevention, [2005] 2005

Clinical trial methodology

Peace, Karl E., 1941-
Boca Raton : Chapman and Hall/CRC Press, c2011. 2011

Clinical trials study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines

Brody, Tom.
London : Academic Press, 2012. 2012

Discussion framework for clinical trial data sharing : guiding principles, elements, and activities.

Washington, District of Columbia : National Academies Press, 2014. 2014

Drug bioequivalence

Washington, D.C. : Office of Technology Assessment : for sale by the Supt. of Docs., U.S. Govt. Print. Off., [1974] 1974

Drug discovery and design medical aspects

Amsterdam ; Washington, D.C. : IOS Press ; Tokyo : Ohmsha, c2002. 2002

Drug safety evaluation

Gad, Shayne C., 1948- author.
Hoboken, New Jersey : Wiley, 2017. 2017

Drugs and laboratory parameters

Caputi, Achille Patrizio.
Torino : SEEd, 2010. 2010

The essential guide to N-of-1 trials in health

Dordrecht, [Netherlands] : Springer, 2015. 2015

The essential guide to pharmacy residency research

Bethesda : American Society of Health-System Pharmacists, [2020] 2020

The essential guide to pharmacy residency research

Bethesda, MD : American Society of Health-System Pharmacists, [2020] 2020

Evidence-based validation of herbal medicine

Amsterdam, Netherlands : Elsevier, [2015] 2015

FDA and the drug development process how the agency ensures that drugs are safe and effective.

Rockville, MD : Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, [2002] 2002

FDA-approved bargain drugs generic products must meet high standards.

Rockville, MD : Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, [2003] 2003

The FDA Commission : the delegation of authority to state and local authorities.

Rockville, Md : U.S. Dept. of Human Services, Public Health Service, Food and Drug Administration, [1986?] 1986

FDA fast track and priority review programs

Thaul, Susan, author.
[Washington, D.C.] : Congressional Research Service, 2018- 2018

Food and Drug Administration FDA faces challenges meeting its growing medical product responsibiliti

United States. Government Accountability Office.
[Washington, D.C.] : U.S. Govt. Accountability Office, [2009] 2009

Guidance for industry addendum to E2C clinical safety data management : periodic safety update repo

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2004] 2004

Guidance for industry CGMP for phase 1 investigational drugs.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research : Office of Regulatory Affairs, [2008] 2008

Guidance for industry drug-induced liver injury, premarketing clinical evaluation.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2007] 2007

Guidance for industry E 11 clinical investigation of medicinal products in the pediatric population.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2000] 2000

Guidance for industry E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic pote

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005] 2005

Guidance for industry E2B(M), data elements for transmission of individual case study reports, quest

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005] 2005

Guidance for industry E2BM data elements for transmission of individual case safety reports.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2002] 2002

Guidance for industry estimating the maximum safe starting dose in initial clinical trials for thera

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2005] 2005

Guidance for industry M3 nonclinical safety studies for the conduct of human clinical trials for pha

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research , [1997] 1997

Guidance for industry process validation, general principles and practices.

Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER) : Center for Veterinary Medicine (CGMP), [2008] 2008

Guidance for industry Q1A(R2) stability testing of new drug substances and products.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2003] 2003

Guidance for industry Q1D bracketing and matrixing designs for stability testing of new drug substan

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2003] 2003

Guidance for industry Q3C impurities, residual solvents.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [1997] 1997

Guidance for industry S1B testing for carcinogenicity of pharmaceuticals.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [1997] 1997

Guidance for industry S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [1997] 1997

Guidance for industry S7B nonclinical evaluation of the potential for delayed ventricular repolariza

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005] 2005

Guidance for industry S8 immunotoxicity studies for human pharmaceuticals.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2006] 2006

Guidance for industry tropical disease priority review vouchers.

Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER), [2008] 2008

Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing author

[Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2008] 2008

Handbook of targeted cancer therapy and immunotherapy

[Place of publication not identified] : Wolters Kluwer Health, 2018. 2018

Healing roots : anthropology in life and medicine

Laplante, Julie, author.
New York, New York ; Oxford, England : berghahn, 2015. 2015

Improving public health promoting safe and effective drug use.

Rockville, MD : Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, [2003] 2003

Negotiating pharmaceutical uncertainty : women's agency in a South African HIV prevention trial

Saethre, Eirik, author.
Nashville, Tennessee : Vanderbilt University Press, 2017. 2017

Pediatric drug research Food and Drug Administration should more efficiently monitor inclusion of mi

United States. General Accounting Office.
[Washington, D.C.] : U.S. General Accounting Office, [2003] 2003

Pharmaceutical drug analysis methodology - theory - instrumentation - pharmaceutical assays - cognot

Kar, Ashutosh.
New Delhi : New Age International (P) Ltd., Publishers, 2005. 2005

Predictive approaches in drug discovery and development biomarkers and in vitro/in vivo correlations

Hoboken, N.J. : Wiley, c2012. 2012

Prostate Cancer Prevention Trial (PCPT).

[Bethesda, Md.] : National Cancer Institute, [2008]. 2008

Revision of the ICH guideline on clinical safety data management data elements for transmission of

[Rockville, MD : Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2005] 2005

Statistical methods for evaluating safety in medical product development

Chichester, England : Wiley, 2015. 2015

Statistical thinking for non-statisticians in drug regulation

Kay, R. (Richard), 1949- author.
Chichester, England : Wiley Blackwell, 2015. 2015