Multi-company multi-country clinical trials
Subtitle: implementation, monitoring, and regulations
By: edited by Rhona Simmons.
Contributors: Simmons, Rhona.
Publisher: Interpharm Press
Published: 1993
Place of publication: Buffalo Grove, IL
Language: eng
Number of pages: 303
Subjects: Clinical trials -- Standards.; Drugs -- Testing -- Standards.
Notes: Includes bibliographical references and index.
Table of contents: title: Structuring multinational collaborative development agreements / Linda J. Nyari; title: Regulatory aspects: biotechnology / Virginia Holcombe and Michele V. McNeill; title: Regulatory aspects of the development of new chemical entities in the United States / Helen P. Shu; title: Collaborative clinical development programs / Vibeke Strand; title: Good clinical practices / Arthur M. Horowitz; title: Pharmaceutical development and GMP: recombinant proteins / Robert Lopez; title: Chemical and pharmaceutical aspects of drug product registration / John Murphy and Katy Morton; title: Computerization in multinational drug development / Michael R. Hamrell; title: FDA clinical audit / Arthur M. Horowitz; title: Phase IV surveillance / Karl Agre; title: Management and implementation of multinational pharmaceutical development programs / Rhona Simmons; title: Information systems validation in global clinical trials / Teri Stokes.