Optimizing the Science of Drug Development: Opportunities for Better Candidate Selection and Accelerated Evaluation in Humans
- 1 August 2000
- journal article
- Published by Wiley in The Journal of Clinical Pharmacology
- Vol. 40 (8) , 803-814
- https://doi.org/10.1177/00912700022009530
Abstract
Two international meetings were convened in 1998 to review the current science of drug development and the potential opportunities to optimize the evaluation of new drugs in humans. This report represents a synopsis of these meetings, and focuses on the current state of knowledge pertaining to drug development, future scientific and technical needs, and the relative merits of various strategies intended to accelerate the clinical development of drugs.Keywords
This publication has 10 references indexed in Scilit:
- Simulation of Clinical TrialsAnnual Review of Pharmacology and Toxicology, 2000
- Pharmacokinetic/Pharmacodynamic Modeling in Drug DevelopmentAnnual Review of Pharmacology and Toxicology, 2000
- Population pharmacokinetics/pharmacodynamics of docetaxel in phase II studies in patients with cancer.Journal of Clinical Oncology, 1998
- An Evaluation of the Integration of Pharmacokinetic and Pharmacodynamic Principles in Clinical Drug DevelopmentClinical Pharmacokinetics, 1997
- Learning versus confirming in clinical drug development*Clinical Pharmacology & Therapeutics, 1997
- Preliminary Pharmacokinetics and Pharmacodynamics of an Ultra-Short-Acting OpioidAnesthesia & Analgesia, 1993
- The Pharmacokinetics of the New Short-acting Opioid Remifentanil (GI87084B) in Healthy Adult Male VolunteersAnesthesiology, 1993
- Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug developmentClinical Pharmacology & Therapeutics, 1992
- Pharmacokinetics, Pharmacodynamics, and Rational Opioid SelectionAnesthesiology, 1991
- Pharmacologically Guided Phase I Clinical Trials Based Upon Preclinical Drug DevelopmentJNCI Journal of the National Cancer Institute, 1990