About FDA
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Selected Pharmacometric Reviews, Guidances, Presentations and Reports
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Selected Pharmacometric Reviews
- Retrovir (zidovudine) Review (PDF - 686KB)
- Valganciclovir hydrochloride Review
- Aptivus (tipranavir) Review (PDF - 1.7MB)
- Atacand (candesartan cilexetil) Review (PDF - 991KB)
- Pharmacometrics-Based Design and Analysis of Pediatric Trials: FDA Presentation Slides (PDF - 70KB)
- Angiomax Injection (bivalirudin) Review (PDF - 1.8MB)
- Videx (didanosine) Review (PDF - 830KB)
- Promacta Review
Cleviprex (clevidipine) review Clinical Pharmacology and Biopharmaceutics Review: Part 1
TMC 125 Etravirine (Pages 7-45)Clinical Pharmacology and Biopharmaceutics Review: Part 5
TMC 125 Etravirine (Pages 76-80)Clinical Pharmacology and Biopharmaceutics Review: Part 6
TMC 125 Etravirine
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Guidances
End-of-Phase 2A Meetings (PDF - 163KB)Population Pharmacokinetics (PDF - 135KB)Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications (PDF - 221KB)E4 Dose-Response Information to Support Drug Registration (PDF - 52KB)International Conference on Harmonization (ICH) - Guidance for Industry: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (PDF) (PDF - 86KB)
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Presentations
- Pharmacometrics 2020 (Gobburu at ACoP)
- Learning from Prior Parkinson’s Disease Clinical Trials (Bhattaram)
Understanding Parkinson’s Disease (Bhattaram) - Non-Small Cell Lung Cancer (Wang) and Pediatrics (Jadhav) at Advisory Committee Meeting 2008
- Tedisamil Advisory Committee Background Material
- Anti-Infective Drugs Advisory Committee Meeting: Clinical Trail Designs for Community Acquired Pneumonia
- Fingolimod Advisory Committee Background Material
- Fingolimod Advisory Committee Slides (Lee)
- Use of PVRI for Approval in Pediatric PAH patients (Brar) (PDF - 756KB)
- Tetrabenazine Advisory Committee Background Material
- Tetrabenazine Advisory Committee Slides (Bhattaram)
- Argatroban Pediatrics (Gobburu) (PDF - 70KB)
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