Optimizing Drug Development Research Articles

Pharmacokinetics/Pharmacodynamics in Drug Development: An Industrial Perspective

In a health care environment dominated by the growth of managed care organizations, generic competition, therapeutic substitution and drug utilization review, drug development is an extremely risky proposition. Consequently, it is imperative to incorporate a mechanistic approach to drug development that combines a thorough understanding of a drug at the molecular/cellular level with a rigorous preclinical, and clinical pharmacology program. This should enable the sponsor to evaluate multiple hypotheses during the early "learning" phases of clinical development (Phases I and IIA) and to eliminate nonpromising candidates early on while drug development costs are low. Clinical research done properly in the early stages of drug development will also set the stage for designing and conducting optimal "confirming" registrational Phase IIB/III studies for promising drug candidates. Pharmacokinetics (PK) and pharmacodynamics (PD) modeling and simulation are crucial components of a mechanistic approach to optimal drug development and their application has significant impact in both early and late development efforts. This communication describes several applications of pharmacokinetics and pharmacodynamics modeling and simulation that were important in guiding, optimizing and ensuring the success of development efforts for drug candidates in the therapeutic areas of cardiology and oncology. These examples are used to illustrate and discuss the use of the current state-of-the-art in pharmacokinetics and pharmacodynamics modeling and simulation at numerous stages in the development cycle and to postulate on future directions in this area.

Alzheimer's Disease: Optimizing Drug Development Strategies

Alzheimer's Disease: Optimizing Drug Development Strategies

Alzheimer's disease: Optimizing drug development strategies. By Neal R. Cutler, John J. Sramek and Amye. Veroff. John Wiley & Sons, Chichester, UK, 1994. ISBN 0–471–951455

Human Psychopharmacology: Clinical and ExperimentalVolume 10, Issue 3 p. 244-245 Book Review Alzheimer's disease: Optimizing drug development strategies. By Neal R. Cutler, John J. Sramek and Amye. Veroff. John Wiley & Sons, Chichester, UK, 1994. ISBN 0–471–951455 B. E. Leonard, B. E. Leonard Galway, IrelandSearch for more papers by this author B. E. Leonard, B. E. Leonard Galway, IrelandSearch for more papers by this author First published: May/June 1995 https://doi.org/10.1002/hup.470100315AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume10, Issue3May/June 1995Pages 244-245 RelatedInformation

Alzheimer's disease, optimizing drug development strategies. Neal R. Cutler, John J. Sramek and Amy E. Veroff, John Wiley, Chichester, UK, 1994, viii+ 168 pages, $65.95

<i>Alzheimer's disease, optimizing drug development strategies</i>. Neal R. Cutler, John J. Sramek and Amy E. Veroff, John Wiley, Chichester, UK, 1994, viii+ 168 pages, $65.95

Alzheimer's disease: Optimizing drug development strategies. By Nealr. Cutler, John J. Sramek and Amy E. Veroff. John Wiley &amp; Sons Ltd, Chichester, 1994. pp. 168 + viii. ISBN 0 471 951455

Human Psychopharmacology: Clinical and ExperimentalVolume 10, Issue 2 p. 160-160 Book Review Alzheimer's disease: Optimizing drug development strategies. By Nealr. Cutler, John J. Sramek and Amy E. Veroff. John Wiley & Sons Ltd, Chichester, 1994. pp. 168 + viii. ISBN 0 471 951455 First published: March/April 1995 https://doi.org/10.1002/hup.470100214AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume10, Issue2March/April 1995Pages 160-160 RelatedInformation