New drug approval process : accelerating global registrations /

New drug approval process /
Published: (1993)

New drug development : regulatory paradigms for clinical pharmacology and biopharmaceutics /
Published: (2004)

The pharmaceutical regulatory process /
Published: (2005)

Ethical issues in drug testing, approval, and pricing : the clot-dissolving drugs /
by: Brody, Baruch A.
Published: (1995)

Pharmacokinetics in drug development /
Published: (2004)

Statistical thinking for non-statisticians in drug regulation /
by: Kay, R. (Richard), 1949-
Published: (2015)

Drugs : from discovery to approval /
by: Ng, Rick
Published: (2004)

A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim /
by: Liu, Margaret B.
Published: (2010)

Pediatric drug development : concepts and applications /
Published: (2013)

Drug products for clinical trials /
Published: (2006)

Cardiovascular drug development : protocol design and methodology /
Published: (1999)

Drug products for clinical trials : an international guide to formulation, production, quality control /
Published: (1998)

The clinical audit in pharmaceutical development /
Published: (2000)

New drug approval : FDA's consideration of evidence from certain clinical trials : report to congressional requesters.
Published: (2010)

Clinical evaluation of medical devices : principles and case studies /
Published: (1998)

Handbook of clinical drug research /
Published: (1986)

New drug approval process : the global challenge /
Published: (2000)

Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines /
by: Brody, Tom
Published: (2012)

Clinical trials /
by: Schwartz, Daniel, 1917-2009
Published: (1980)

Anticancer drug development guide : preclinical screening, clinical trials, and approval /
Published: (2004)

Guidance for industry : submitting marketing applications according to the ICH-CTD format, general considerations.
Published: (2001)

Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines /
by: Brody, Tom
Published: (2016)

Methodology of clinical drug trials /
by: Spriet, Alain
Published: (1985)

A first-order characterization of clinical trials /
by: Hopwood, Marsha
Published: (1980)

The Clinical research process in the pharmaceutical industry /
Published: (1984)

Statistical thinking for non-statisticians in drug regulation /
by: Kay, R. (Richard), 1949-
Published: (2007)

Drug safety assessment in clinical trials /
Published: (1993)

Clinical pharmacology in drug development.
Published: (2012)

Lessons from a horse named Jim : a clinical trials manual from the Duke Clinical Research Institute /
by: Liu, Margaret B.

Clinical drug trials and tribulations /
Published: (1988)

Human experimentation : methodologic issues fundamental to clinical trials /
by: Cleophas, Ton J. M.
Published: (1999)

Statistical methods for evaluating safety in medical product development /
Published: (2014)

Managing the clinical drug development process /
by: Cocchetto, David M., 1953-
Published: (1992)

Intelligent drug development : trials and errors in clinical research /
by: Tansey, Michael
Published: (2020)

New drug approval : FDA needs to enhance its oversight of drugs approved on the basis of surrogate endpoints : report to the Ranking Member, Committee on Finance, U.S. Senate.
Published: (2009)

Biopharmaceutical sequential statistical applications /
Published: (1992)