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|a 363.19/46/0973
|2 20
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|
|a QV 771
|b N5318 1993
|
| 245 |
0 |
0 |
|a New drug approval process /
|c edited by Richard A. Guarino.
|
| 250 |
|
|
|a Second edition, revised & expanded.
|
| 264 |
|
1 |
|a New York :
|b M. Dekker,
|c [1993]
|
| 264 |
|
4 |
|c ©1993
|
| 300 |
|
|
|a xxi, 469 pages :
|b illustrations ;
|c 24 cm.
|
| 336 |
|
|
|a text
|2 rdacontent
|b txt
|
| 337 |
|
|
|a unmediated
|2 rdamedia
|
| 338 |
|
|
|a volume
|2 rdacarrier
|b nc
|
| 490 |
1 |
|
|a Drugs and the pharmaceutical sciences ;
|v v. 56
|
| 504 |
|
|
|a Includes bibliographical references and index.
|
| 505 |
0 |
|
|a 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.
|
| 505 |
0 |
|
|a (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.
|
| 610 |
1 |
0 |
|a United States.
|b Food and Drug Administration.
|
| 650 |
|
2 |
|a Clinical Trials as Topic
|x standards
|z United States.
|
| 650 |
|
2 |
|a Drug Evaluation
|x standards
|z United States.
|
| 700 |
1 |
|
|a Guarino, Richard A.,
|d 1935-
|
| 830 |
|
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|a Drugs and the pharmaceutical sciences ;
|v v. 56.
|
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|a MARS
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|a Texas A&M University
|b Rellis Campus
|c Joint Library Facility
|d Remote Storage
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|e QV 771 N5318 1993
|h National Library of Medicine classification
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|m 3238901362969
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| 998 |
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