Results 181 to 190 of about 5,545,002 (288)

Federal Advisory Committees, Policy Expertise, and the Approval of Drugs and Medical Devices at the FDA [PDF]

, 2010
Stéphane Lavertu, David L. Weimer
openalex   +1 more source

The evolutionary safety of mutagenic drugs should be assessed before drug approval. [PDF]

PLoS Biol
Lobinska G, Tretyachenko V, Dahan O, Nowak MA, Pilpel Y.   +4 more
europepmc   +1 more source

Clinical Trial Design and Drug Approval in Oncology: A Primer for the Advanced Practitioner in Oncology. [PDF]

J Adv Pract Oncol, 2020
Kurtin SE, Taher R.
europepmc   +1 more source

ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials

Annals of Internal Medicine, 2016
Lisa M. Schwartz, S. Woloshin, Eugene Zheng, Tony Tse, D. Zarin   +4 more
semanticscholar   +1 more source

Making Drug Approval Decisions in the Face of Uncertainty: Cumulative Evidence versus Value of Information. [PDF]

Med Decis Making
Dijk SW, Krijkamp E, Kunst N, Labrecque JA, Gross CP, Pandit A, Lu CP, Visser LE, Wong JB, Hunink MGM.   +9 more
europepmc   +1 more source

Impact of pharmacometrics on drug approval and labeling decisions: A survey of 42 new drug applications

, 2005
Venkatesh Atul Bhattaram, Brian Booth, Roshni Ramchandani, B. Nhi Beasley, Yaning Wang, Veneeta Tandon, John Duan, Raman Baweja, Patrick Marroum, Ramana Uppoor, Nam Atiqur Rahman, Chandrahas Sahajwalla, J. Robert Powell, Mehul U. Mehta, Jogarao Gobburu   +14 more
openalex   +2 more sources

Regulatory Approval of Cancer Risk-Reducing (Chemopreventive) Drugs: Moving What We Have Learned into the Clinic [PDF]

, 2011
Frank L. Meyskens, Gregory A. Curt, Dean E. Brenner, Gary Gordon, Ronald B. Herberman, Olivera J. Finn, Gary J. Kelloff, Samir N. Khleif, Caroline C. Sigman, Éva Szabó   +9 more
openalex   +1 more source

Machine Learning with Statistical Imputation for Predicting Drug Approval

Harvard Data Science Review, 2021
Andrew W. Lo, Kien Wei Siah, Chi Heem Wong   +2 more
doaj   +1 more source

Surrogate Markers and Drug Approvals [PDF]

Hospital Pharmacy, 2016
openaire   +3 more sources

PHP94 THE ROLE OF HEALTH-RELATED QUALITY OF LIFE DATA IN THE DRUG APPROVAL PROCESSES IN THE UNITED STATES AND EUROPE: A REVIEW OF GUIDANCE DOCUMENTS AND AUTHORIZATIONS OF MEDICINAL PRODUCTS FROM 2006 TO 2010 [PDF]

, 2011
Patrick Marquis, M. Caron, M.P. Emery, Scott K. Jelinek, C. Acquadro   +4 more
openalex   +1 more source