TY  - BOOK
AU  - Welling,Peter G.
AU  - Lasagna,Louis
AU  - Banakar,Umesh V.
TI  - The drug development process
SN  - 0824797272 (hc : acidfree paper)
AV  - RM301.25 .D77 1996
U1  - 615.19 20
PY  - 1996///]
CY  - New York
PB  - M. Dekker
KW  - Drug development
KW  - Pharmaceutical industry
KW  - Drug Evaluation
KW  - Drug Screening
KW  - Drug Industry
KW  - organization & administration
KW  - Drug Design
N1  - Includes bibliographical references and index; Cover; Half Title; Title Page; Copyright Page; Foreword; Preface; Introduction: Whither Drug Development?; Table of Contents; Contributors; Part I: Changing Perspectives in Drug Development; 1. The Evolving Drug Discovery and Development Process; 2. Redefining Competition in the Pharmaceutical Industry: A Time for Choice; Part II: Process Challenges in Drug Development; 3. The Impact of Liability and Cost Containment on the Drug Development Process; 4. Managing the Overall Portfolio for Successful Discovery and Development; Part III: Pharmaceutical and Formulation Factors. 5. Pharmaceutical Issues in Drug Development6. Novel Drug Delivery Systems; Part IV: Drug Design, Pharmacokinetics, and Toxicology; 7. Computer-Aided Drug Design; 8. New Approaches to Nonclinical Biodisposition Studies; 9. Changes in Pharmacokinetics and Drug Metabolism Responsibility in Drug Discovery and Development; Part V: Chemotherapy; 10. Anticancer Drug Development; Part VI: Clinical Studies and the Use of Clinical Research Organizations; 11. Clinical Pharmacology in Drug Development: A View to Future Effectiveness. 12. Contracting CROs into Your Organization: New Strategies for New Challenges13. The Role of Clinical Research Organizations in Drug Development; Part VII: European and Japanese Approaches; 14. Understanding Drug Development and Registration in Japan; 15. Increasing the Effectiveness of Clinical Pathology Testing and Its Value to Drug Development in Europe; 16. New Marketing Authorization Procedures in the European Union and the Impact on Regulatory Strategy; Index

N2  - "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."--Provided by publisher

UR  - http://www.loc.gov/catdir/enhancements/fy0647/96024681-d.html
ER  -