scholarly journals A Challenge for Clinical Pharmacologists: How Can We Measure Scientific Impact of Publications in Drug Development and in Regulatory Decision Making?

2018 ◽  
Vol 105 (5) ◽  
pp. 1071-1073
Author(s):  
Virginia D. Schmith ◽  
Kellie Schoolar Reynolds ◽  
Kim L.R. Brouwer ◽  
Paolo Vicini
Keyword(s):  
Decision Making ◽  
Drug Development ◽  
Scientific Impact ◽  
Regulatory Decision

scholarly journals Physiologically Based Pharmacokinetics Is Impacting Drug Development and Regulatory Decision Making

2015 ◽  
Vol 4 (6) ◽  
pp. 313-315 ◽  
Author(s):  
M Rowland ◽  
LJ Lesko ◽  
A Rostami-Hodjegan
Keyword(s):  
Decision Making ◽  
Drug Development ◽  
Physiologically Based Pharmacokinetics ◽  
Regulatory Decision ◽  
Physiologically Based

Patient opinions and preferences in drug development and regulatory decision making

2011 ◽  
Vol 8 (1) ◽  
pp. e11-e14 ◽  
Author(s):  
Alasdair Breckenridge
Keyword(s):  
Decision Making ◽  
Drug Development ◽  
Regulatory Decision

Pharmacogenomics in Drug Development and Regulatory Decision-making: the Genomic Data Submission (GDS) Proposal

2004 ◽  
Vol 5 (1) ◽  
pp. 25-30 ◽  
Author(s):  
Ronald A Salerno ◽  
Lawrence J Lesko
Keyword(s):  
Decision Making ◽  
Drug Development ◽  
Genomic Data ◽  
Data Submission ◽  
Regulatory Decision

scholarly journals Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Decision Making: Report of the First FDA-PWG-PhRMA-DruSafe Workshop

2003 ◽  
Vol 43 (4) ◽  
pp. 342-358 ◽  
Author(s):  
Lawrence J. Lesko ◽  
Ronald A. Salerno ◽  
Brian B. Spear ◽  
Donald C. Anderson ◽  
Timothy Anderson ◽  
...  
Keyword(s):  
Decision Making ◽  
Drug Development ◽  
Regulatory Decision

Incorporating patient preferences into drug development and regulatory decision making: Results from a quantitative pilot study with cancer patients, carers, and regulators

2016 ◽  
Vol 99 (5) ◽  
pp. 548-554 ◽  
Author(s):  
D Postmus ◽  
M Mavris ◽  
HL Hillege ◽  
T Salmonson ◽  
B Ryll ◽  
...  
Keyword(s):  
Decision Making ◽  
Pilot Study ◽  
Drug Development ◽  
Cancer Patients ◽  
Patient Preferences ◽  
Regulatory Decision

Introduction to Drug Development and Regulatory Decision-Making

2004 ◽  
pp. 1-11
Author(s):  
Lawrence Lesko ◽  
Chandrahas Sahajwalla
Keyword(s):  
Decision Making ◽  
Drug Development ◽  
Regulatory Decision
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