New drug approval process /

Bibliographic Details
Other Authors:	Guarino, Richard A., 1935-
Format:	Book
Language:	English
Published:	New York : M. Dekker, [1993]
Edition:	Second edition, revised & expanded.
Series:	Drugs and the pharmaceutical sciences ; v. 56.
Subjects:	United States. > Food and Drug Administration. Clinical Trials as Topic > standards > United States. Drug Evaluation > standards > United States.

Table of Contents:

Nonclinical research evaluation: pharmacology, toxicology, pharmacokinetics / Raymond E. Stoll, Mark Calcamuggio
IND and clinical investigator's brochure / Stacy Rosenfeld-Bate, Mark Calcamuggio
Clinical research protocols / Richard A. Guarino
Clinical development of OTC drugs / Bernard P. Schachtel
Statistical and data management collaboration in clinical research / Guy M. Cohen
Biotechnology: ELAs and PLAs / James J. Conklin
Image processing techniques applied to drug and medical device development / James J. Conklin, Harry L. Loats, Andrew S. Loats
Industry and FDA liaison / William M. Troetel
Obligations of investigator, sponsor, and monitor / Richard A. Guarino
Management of clinical studies / Robert McCormack
Adverse reactions and interactions of drugs / Richard A. Guarino, R. Dorrien Venn
Institutional review boards, informed consent, and auditing / Thomas J. Hynds
General considerations of the NDA / Andrew G. Clair, Lloyd G. Milstein
Specific requirements, content, and format of an NDA / Aileen Ryan, Mark Calcamuggio.
(cont) Manufacturing and control requirements of the NDA and ANDA / M. Douglas Winship, Robert McCormack
Drug product labeling / Lloyd G. Millstein
Drugs for serious, life-threatening diseases: a special FDA liaison / Andrew G. Clair
Regulations for OTC drugs / William E. Gilbertson
Abbreviated and supplemental drug applications / William M. Troetel
Orphan drug / Aileen Ryan.