Course: Principles of Drug Development

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Session Topic Readings
1 True Tales from the Annals of Drug Development - Charles Flexner

Strizki JM, et al. Discovery and characterization of vicriviroc (SCH 417690), a CCR5 antagonist with potent activity against human immunodeficiency virus type 1. Antimicrob Agents Chemother. 2005 Dec;49(12):4911-9.

Idemyor V. Human immunodeficiency virus (HIV) entry inhibitors (CCR5 specific blockers) in development: are they the next novel therapies? HIV Clin Trials. 2005 Sep-Oct;6(5):272-7.

Phase I: Types of Studies

Statistics for Toxicity in Phase I Escalation

2 Phase I Studies - Charles Flexner Hendrix CW, et al. Pharmacokinetics and safety of AMD-3100, a novel antagonist of the CXCR-4 chemokine receptor, in human volunteers. Antimicrob Agents Chemother 2000; 44: 1667-1673.
3 Phase II Studies - Charles Flexner Flexner C, et al. Pharmacokinetics, toxicity, and activity of intravenous dextran sulfate in human immunodeficiency virus infection. Antimicrob Agents Chemother 1991; 35: 2544-2550.
4 How the FDA and the Pharmaceutical Industry Work: An Insider's Guide - Carol Trapnell No reading
5 Phase III Studies - Charles Flexner Slamon DJ, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med . 2001 Mar 15;344(11):783-92.
6 Device and Diagnostic Test Development - Charles Flexner No reading
7 Phase IV Studies and Pharmacoepidemiology No reading