書誌事項

The drug development process

edited by Peter G. Welling, Louis Lasagna, Umesh V. Banakar

(Drugs and the pharmaceutical sciences, v. 76)

Marcel Dekker, c1996

タイトル別名

The drug development process : increasing efficiency and cost-effectiveness

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注記

Includes bibliographical references and index

内容説明・目次

内容説明

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.

目次

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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