The Drug Development Process: Increasing Efficiency and Cost-Effectiveness

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Containing contributions from the many disciplines involved in a drug's evolution, this timely volume examines the entire pharmaceutical development process, emphasizing approaches to increasing efficiency and reducing costs.

The book contains black-and-white illustrations.

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Overview

Containing contributions from the many disciplines involved in a drug's evolution, this timely volume examines the entire pharmaceutical development process, emphasizing approaches to increasing efficiency and reducing costs.

The book contains black-and-white illustrations.

Read More Show Less

Editorial Reviews

Doody's Review Service
Reviewer: Eric Goll, PharmD (University of Illinois at Chicago College of Pharmacy)
Description: This compilation of topics is designed expressly to challenge current approaches to the drug development process. Experts contributed chapters representing the many disciplines involved in drug development. The chapter topics include the evolution of drug discovery and development, impact of liability and cost containment, pharmaceutical issues, drug design, pharmacokinetics, clinical pharmacology, management (use of clinical research organizations), and regulatory affairs. The stated objective of the editors and chapter authors is to increase the reader's awareness of the challenges of drug development and present alternatives that might help improve what is considered an inefficient process.
Purpose: Current pressures of cost containment on the pharmaceutical industry has made drug development a timely and important topic. The book does provoke the reader's awareness when discussing the challenges and opportunities facing the drug development process.
Audience: The contributors represent the specialties of clinical pathology, pharmacology, and research. A majority of the contributors are associated with a pharmaceutical corporation. In view of the complexity of the book and background of the authors, the book is intended primarily for use by pharmaceutical scientists or pharmacologists.
Features: All three editors have strong achievements in research and the drug development process. They efficiently utilize a variety of tables, flow charts, bar graphs, and diagrams to illustrate the book. The book is well referenced.
Assessment: This publication provides the serious reader with a thorough description of the drug development process, emphasizing alternatives for increasing efficiency and containing costs. The book seemed somewhat biased to an industry perspective. It would have been of benefit to include a chapter on the FDA's viewpoint. Due to the book's complex nature, it will have a limited audience. However, individuals working in regulatory, academic, and industrial environments will find the book stimulating.
Eric Goll
This compilation of topics is designed expressly to challenge current approaches to the drug development process. Experts contributed chapters representing the many disciplines involved in drug development. The chapter topics include the evolution of drug discovery and development, impact of liability and cost containment, pharmaceutical issues, drug design, pharmacokinetics, clinical pharmacology, management (use of clinical research organizations), and regulatory affairs. The stated objective of the editors and chapter authors is to increase the reader's awareness of the challenges of drug development and present alternatives that might help improve what is considered an inefficient process. Current pressures of cost containment on the pharmaceutical industry has made drug development a timely and important topic. The book does provoke the reader's awareness when discussing the challenges and opportunities facing the drug development process. The contributors represent the specialties of clinical pathology, pharmacology, and research. A majority of the contributors are associated with a pharmaceutical corporation. In view of the complexity of the book and background of the authors, the book is intended primarily for use by pharmaceutical scientists or pharmacologists. All three editors have strong achievements in research and the drug development process. They efficiently utilize a variety of tables, flow charts, bar graphs, and diagrams to illustrate the book. The book is well referenced. This publication provides the serious reader with a thorough description of the drug development process, emphasizing alternatives for increasing efficiency and containing costs. The bookseemed somewhat biased to an industry perspective. It would have been of benefit to include a chapter on the FDA's viewpoint. Due to the book's complex nature, it will have a limited audience. However, individuals working in regulatory, academic, and industrial environments will find the book stimulating.
Booknews
Sixteen invited essays responding to the challenges facing the pharmaceutical industry and government regulators who must create more cost-effective approaches to the development and marketing of drugs. The contributors consider redefined competition in drug discoveries and development, the impact of liability on cost containment in the process, novel drug delivery systems, computer aided drug design, the use of clinical research, and a comparative analysis of European and Japanese approaches to management, development, and regulation. Annotation c. Book News, Inc., Portland, OR (booknews.com)

3 Stars from Doody
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Product Details

  • ISBN-13: 9780824797270
  • Publisher: Taylor & Francis
  • Publication date: 8/15/1996
  • Series: Drugs and the Pharmaceutical Sciences Series
  • Edition description: New Edition
  • Edition number: 1
  • Pages: 472
  • Product dimensions: 6.25 (w) x 9.25 (h) x 1.06 (d)

Table of Contents

Changing Perspectives in Drug Development

The Evolving Drug Discovery and Development Process, John C. Somberg Redefining Competition in the Pharmaceutical Industry: A Time for Choice, John Thompson and Jan Gugliotti

Process Challenges in Drug Development

The Impact of Liability and Cost Containment on the Drug Development Process, Martha M. Rumore Managing the Overall Portfolio for Successful Discover and Development, Rebecca J. Anderson

Pharmaceutical and Formulation Factors

Pharmaceutical Issues in Drug Development, Umesh V. Banakar and Michael C. Makoid Novel Drug Delivery Systems, Bret Berner and Agis Kydonieus

Drug Design, Pharmacokinetics, and Toxicology

Computer-Aided Drug Design, Terry R. Stouch New Approaches to Nonclinical Biodisposition Studies, D. Bruce Campbell Changes in Pharmacokinetics and Drug Metabolism Responsability in Drug Discovery and Development, Peter G. Welling

Chemotherapy

Anticancer Drug Development, Jim Cassidy

Clinical Studies and the Use of Clinical Research Organizations

Clinical Pharmacology in Drug Development: A View to Future Effectiveness, J. Robert Powell, Alan Bye, and Paul D. Rubin Contracting CROs in Your Organization: New Strategies for New Challenges, Gary D. Lightfoot and John R. Vogel The Role of Clinical Research Organizations in Drug Development, Albert J. Siemens and James E. Higgins

European and Japanese Approaches

Understanding Drug Development and Registration in Japan, W. J. C. Currie Increasing the Effectiveness of Clinical Pathology Testing and its Value to Drug Development in Europe, Dai Davies and Karolyn Jackson New Marketing Authorization Procedures in the European Union and the Impact on Regulatory Strategy, Vaila M. Marshall

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