TY  - BOOK
AU  - Guarino,Richard A.
TI  - New drug approval process: accelerating global registrations 
T2  - Drugs and the pharmaceutical sciences
SN  - 0824750411
U1  - 615.1 22
PY  - 2004///]
CY  - New York
PB  - Marcel Dekker Inc.
KW  - Drug approval
KW  - United States
KW  - Drugs
KW  - Testing
KW  - Standards
KW  - Government policy
KW  - New products
KW  - Clinical Trials as Topic
KW  - standards
KW  - Drug Evaluation
KW  - Drug Approval
N1  - 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
ER  -