Research Catalog
New drug approval process
- Title
- New drug approval process / edited by Richard A. Guarino.
- Publication
- New York : M. Dekker, ©1993.
Items in the Library & Off-site
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1 Item
| Status | Format | Access | Call Number | Item Location |
|---|---|---|---|---|
| Text | Use in library | RS189 .N475 1993 | Off-site |
Details
- Additional Authors
- Guarino, Richard A., 1935-
- Description
- xxi, 469 pages : illustrations; 24 cm.
- Series Statement
- Drugs and the pharmaceutical sciences ; v. 56
- Uniform Title
- Drugs and the pharmaceutical sciences ; v. 56.
- Subject
- Drug approval > United States
- Drugs > Testing > Standards
- Drugs > Testing > Government policy > United States
- New products > Government policy > United States
- Clinical Trials as Topic > standards
- Drug Evaluation > standards
- Drug approval
- Drugs > Testing > Government policy
- New products > Government policy
- Évaluation de médicament > Normes de référence > États-Unis
- Essais cliniques comme sujet > Normes de référence > États-Unis
- Arzneimittelprüfung
- Richtlinie
- Médicaments > Normes > États-Unis
- Politique pharmaceutique > États-Unis
- United States
- United States
- USA
- Bibliography (note)
- Includes bibliographical references and index.
- 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.
- ISBN
- 082478801X
- 9780824788018
- LCCN
- 92023366
- OCLC
- ocm26300563
- 26300563
- SCSB-2037942
- Owning Institutions
- Princeton University Library