Ethical issues in drug testing, approval, and pricing : the clot-dissolving drugs /

New drug approval in the United States /
by: Mathieu, Mark P.
Published: (1995)

Limitation of infarct size with thrombolytic agents : November 9-10, 1981, Lister Hill Center Auditorium, National Institutes of Health, Bethesda, Maryland /
Published: (1983)

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

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

Anticoagulants, antiplatelets, and thrombolytics /
Published: (2004)

New drug development : a regulatory overview /
by: Mathieu, Mark P.
Published: (1997)

Pharmacokinetics in drug development /
Published: (2004)

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

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

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

The pharmaceutical regulatory process /
Published: (2005)

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

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

Optimizing the development of antipsychotic drugs /
Published: (1997)

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

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

New drug approval process /
Published: (1993)

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

Handbook of clinical drug research /
Published: (1986)

Clinical drug trials and tribulations /
Published: (1988)

New drug approval process : clinical and regulatory management /
Published: (1987)

Guidebook for drug regulatory submissions /
by: Weinberg, Sandy, 1950-
Published: (2009)

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)

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

Clinical, interventional, and investigational thrombocardiology /
Published: (2005)

Guidance for industry : antibacterial drug products, use of noninferiority studies to support approval.
Published: (2007)

Drugs@FDA.

Anticancer drug development : proceedings of the 1st International Symposium on Management and Realization of Anticancer Drug Development held in Granada, Spain on March 25-26, 1982 /
Published: (1983)

Guidance for industry : M4E, the CTD, efficacy.
Published: (2001)

Clinical pharmacology in drug development.
Published: (2012)

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

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

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

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

FDA's drug review process and the package label : strategies for writing successful FDA submissions /
by: Brody, Tom
Published: (2017)

Antithrombotics /
Published: (1999)