New drug approval process : accelerating global registrations /
New drug approval process : accelerating global registrations /
edited by Richard A. Guarino, M.D., oxford pharmaceutical resources, inc., Totowa, New Jersey, U.S.A.
- Fourth edition
- xiv, 635 pages : illustrations (black and white) ; 24 cm
- Drugs and the pharmaceutical sciences ; v. 139 .
- Drugs and the pharmaceutical sciences .
Includes bibliographical references and index
pt. 1. Regulatory practices and procedures of new drug, biologic, and device development --
pt. 2. Clinical research development --
pt. 3. Specific aspects in the process of new product submissions --
pt. 4. Global applications of good clinical practices (GCPs) --
pt. 5. Effective and new methodologies in expediting new product approvals in the U.S. and European Union.
0824750411
Drug approval--United States
Drugs--Testing--Standards
Drugs--Testing--Government policy--United States
New products--Government policy--United States
Clinical Trials as Topic--standards--United States
Drug Evaluation--standards--United States
Drug Approval--standards--United States
615.1 / N.
Includes bibliographical references and index
pt. 1. Regulatory practices and procedures of new drug, biologic, and device development --
pt. 2. Clinical research development --
pt. 3. Specific aspects in the process of new product submissions --
pt. 4. Global applications of good clinical practices (GCPs) --
pt. 5. Effective and new methodologies in expediting new product approvals in the U.S. and European Union.
0824750411
Drug approval--United States
Drugs--Testing--Standards
Drugs--Testing--Government policy--United States
New products--Government policy--United States
Clinical Trials as Topic--standards--United States
Drug Evaluation--standards--United States
Drug Approval--standards--United States
615.1 / N.