The Importance of Cost-Effectiveness in New Drug Approval: Stroke Burden and Tenecteplase Efficacy. [PDF]
J Clin NeurolKwon HS, Kim BJ.
europepmc +1 more source
Risk-benefit evaluation in approval of traditional and innovative drugs
, 2003 Rashmi R. Shah
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Drug development for leukemia: comprehensive analysis of clinical trials from first report to drug approval. [PDF]
Blood AdvTjioe KC +7 more
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Using Dose-Escalation and -Expansion Cohort Study as Pivotal Trial for Targeted Anticancer Drug Approval. [PDF]
JCO Precis OncolHuang Y, Zhu T, Zhong J, Yuan J.
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U.S. Food and Drug Administration Approval: Panitumumab for Epidermal Growth Factor Receptor–Expressing Metastatic Colorectal Carcinoma with Progression Following Fluoropyrimidine-, Oxaliplatin-, and Irinotecan-Containing Chemotherapy Regimens [PDF]
, 2008 Ruthann M. Giusti +12 more
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Dose Determinations at Drug Approval Reviews: FDA-Approved Drugs in Past 5 Years. [PDF]
Clin Pharmacol TherMita S, Ono S.
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Organizational Scope and Investment: Evidence from the Drug Development Strategies and Performance of Biopharmaceutical Firms [PDF]
This paper compares the clinical trial strategies and performance of large, established ("mature") biopharmaceutical firms to those of smaller ("early stage") firms that have not yet successfully developed a drug.
David Scharfstein, Ilan Guedj
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Predictors of orphan drug approval in the European Union [PDF]
, 2008 Harald E. Heemstra +4 more
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Children With Inflammatory Bowel Diseases are Disadvantaged by Current Drug Approval Policies: A Call for Urgent Change. [PDF]
Crohns Colitis 360Sahn B, Maltz RM, Rosh JR.
europepmc +1 more source
Are Quality of Randomized Clinical Trials and ESMO-Magnitude of Clinical Benefit Scale Two Sides of the Same Coin, to Grade Recommendations for Drug Approval? [PDF]
J Clin Med, 2021 Rodriguez A +4 more
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