Preparing for FDA pre-approval inspections:
"This one-of-a-kind reference clarifies FDA requirements for the manufacture of clinical trial material as well as product development activities and suggests strategies that will facilitate FDA authorization to market." "Featuring key bibliographic references, tables, and drawings, P...
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
New York [u.a.]
Dekker
1999
|
| Schriftenreihe: | Drugs and the pharmaceutical sciences
93 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Zusammenfassung: | "This one-of-a-kind reference clarifies FDA requirements for the manufacture of clinical trial material as well as product development activities and suggests strategies that will facilitate FDA authorization to market." "Featuring key bibliographic references, tables, and drawings, Preparing for FDA Pre-Approval Inspections will be prized by pharmaceutical scientists, manufacturers, and engineers; drug quality assurance, quality control, and regulatory personnel; and pharmacologists."--BOOK JACKET. |
| Beschreibung: | IX, 284 S. graph. Darst. |
| ISBN: | 0824702182 |
Internformat
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Datensatz im Suchindex
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| adam_text | PREPARING FOR FDA PNEAPPROVAL INSPECTIONS EDITED BY MARTIN D. HYNES II
ELI LILLY AND COMPANY INDIANAPOLIS, INDIANA MARCEL DEKKER, INC. NEW YORK
* BASEL * HONG KONG CONTENTS PREFACE V CONTRIBUTORS IX 1. INTRODUCTION
TO FOOD AND DRUG ADMINISTRATION PRE-NEW DRUG APPLICATIONS APPROVAL
INSPECTIONS 1 MARTIN D. HYNES III 2. DEVELOPING A STRATEGIC APPROACH TO
PREPARING FOR A SUCCESSFUL PRE-NDA APPROVAL INSPECTION 11 MARTIN D.
HYNES III 3. FOOD AND DRUG ADMINISTRATION INTERNATIONAL PRE-APPROVAL
INSPECTIONS 31 RONALD F. TETZLAFFAND PETER D. SMITH 4. STABILITY DATA
AND PRE-APPROVAL INSPECTIONS 95 CHRISTOPHER T. RHODES 5. CONSEQUENCES OF
FAILING A PRE-APPROVAL INSPECTION 119 ARTHUR N. LEVINE 6. SUCCESSFUL
MANAGEMENT OF A PRE-APPROVAL INSPECTION 143 PAUL E. WRAY 7. THE
VALIDATION OF PHARMACEUTICAL PROCESSES 161 ROBERT A. NASH 8.
DOCUMENTATION STANDARDS FOR PRE-APPROVAL INSPECTIONS 187 RICHARD M.
JUSTICE, JR. VII VIII CONTENTS 9. TECHNOLOGY TRANSFER AND SCALE-UP 215
ELIZABETH MACLENNAN TROLL 10. TRAINING OF PERSONNEL IN THE
PHARMACEUTICAL INDUSTRY 233 TARA V. SAMS 11. COMPLIANCE WITH CURRENT
GOOD MANUFACTURING PRACTICES AND APPLICATION COMMITMENTS 245 ANTHONY C.
CELESTE INDEX 279
|
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| spelling | Preparing for FDA pre-approval inspections ed. by Martin D. Hynes New York [u.a.] Dekker 1999 IX, 284 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Drugs and the pharmaceutical sciences 93 "This one-of-a-kind reference clarifies FDA requirements for the manufacture of clinical trial material as well as product development activities and suggests strategies that will facilitate FDA authorization to market." "Featuring key bibliographic references, tables, and drawings, Preparing for FDA Pre-Approval Inspections will be prized by pharmaceutical scientists, manufacturers, and engineers; drug quality assurance, quality control, and regulatory personnel; and pharmacologists."--BOOK JACKET. États-Unis - Food and Drug Administration United States. Food and Drug Administration USA Food and Drug Administration (DE-588)10985-X gnd rswk-swf Médicaments - Recherche - Normes - États-Unis Drug Approval United States Drug Industry standards United States Drugs Research Standards United States Laboratories standards United States Arzneimittel (DE-588)4003115-9 gnd rswk-swf Zulassung (DE-588)4127410-6 gnd rswk-swf USA (DE-588)4143413-4 Aufsatzsammlung gnd-content USA Food and Drug Administration (DE-588)10985-X b Arzneimittel (DE-588)4003115-9 s Zulassung (DE-588)4127410-6 s DE-604 Hynes, Martin D. Sonstige oth Drugs and the pharmaceutical sciences 93 (DE-604)BV000002008 93 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008368690&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Preparing for FDA pre-approval inspections Drugs and the pharmaceutical sciences États-Unis - Food and Drug Administration United States. Food and Drug Administration USA Food and Drug Administration (DE-588)10985-X gnd Médicaments - Recherche - Normes - États-Unis Drug Approval United States Drug Industry standards United States Drugs Research Standards United States Laboratories standards United States Arzneimittel (DE-588)4003115-9 gnd Zulassung (DE-588)4127410-6 gnd |
| subject_GND | (DE-588)10985-X (DE-588)4003115-9 (DE-588)4127410-6 (DE-588)4143413-4 |
| title | Preparing for FDA pre-approval inspections |
| title_auth | Preparing for FDA pre-approval inspections |
| title_exact_search | Preparing for FDA pre-approval inspections |
| title_full | Preparing for FDA pre-approval inspections ed. by Martin D. Hynes |
| title_fullStr | Preparing for FDA pre-approval inspections ed. by Martin D. Hynes |
| title_full_unstemmed | Preparing for FDA pre-approval inspections ed. by Martin D. Hynes |
| title_short | Preparing for FDA pre-approval inspections |
| title_sort | preparing for fda pre approval inspections |
| topic | États-Unis - Food and Drug Administration United States. Food and Drug Administration USA Food and Drug Administration (DE-588)10985-X gnd Médicaments - Recherche - Normes - États-Unis Drug Approval United States Drug Industry standards United States Drugs Research Standards United States Laboratories standards United States Arzneimittel (DE-588)4003115-9 gnd Zulassung (DE-588)4127410-6 gnd |
| topic_facet | États-Unis - Food and Drug Administration United States. Food and Drug Administration USA Food and Drug Administration Médicaments - Recherche - Normes - États-Unis Drug Approval United States Drug Industry standards United States Drugs Research Standards United States Laboratories standards United States Arzneimittel Zulassung USA Aufsatzsammlung |
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