New drug approval process:
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
New York [u.a.]
Dekker
1993
|
| Ausgabe: | 2. ed., rev. and expanded |
| Schriftenreihe: | Drugs and the pharmaceutical sciences
30 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XV, 469 S. |
| ISBN: | 082478801X |
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Datensatz im Suchindex
| _version_ | 1804120904936980480 |
|---|---|
| adam_text | APPROUAL PROCESS SECOND EDITION, REUISED AND EIIPANDED I RICHARD A!
T5IRINO,M.N OXFORD RESEARCH INTERNATIONAL CORP. CLIFTON, NEW JERSEY
MARCEL DEKKER, INC. NEW YORK * BASEL * HONG KONG CONTENTS PREFACE V
CONTRIBUTORS XVII INTRODUCTION XIX 1 NONCLINICAL RESEARCH EVALUATION:
PHARMACOLOGY, . TOXICOLOGY, PHARMACOKINETICS * RAYMOND E. STOLL, MARK
CALCAMUGGIO INTRODUCTION NONCLINICAL REQUIREMENTS FOR THE IND AND NDA
PHARMACOLOGY TOXICOLOGY MUTAGENICITY PHARMACOKINETICS CONCLUSION
REFERENCES 1 3 5 9 26 27 34 34 VII VIII CONTENTS 2 THE IND AND CLINICAL
INVESTIGATOR S BROCHURE 39 STACY ROSENFELD-BATE, MARK CALCAMUGGIO
INTRODUCTION PART I: THE IND EXEMPTIONS WAIVERS PHASES OF A CLINICAL
INVESTIGATION PRINCIPLES OF THE IND SUBMISSION FORMAT AND CONTENT OF AN
IND IND AMENDMENTS IND SAFETY REPORTS IND ANNUAL REPORTS WITHDRAWAL OF
AN IND REQUIREMENTS FOR USE OF AN IND IN A CLINICAL STUDY AND CLINICAL
HOLDS INACTIVE STATUS TREATMENT USE OF AN INVESTIGATIONAL NEW DRUG
EMERGENCY USE OF AN INVESTIGATIONAL NEW DRUG PART II: THE INVESTIGATOR S
BROCHURE INTRODUCTION THE CFR DESCRIPTION CONTENT OF THE INVESTIGATOR S
BROCHURE CONCLUSION 39 40 40 40 41 42 42 51 52 52 53 54 54 55 56 56 56
57 58 63 CLINICAL RESEARCH PROTOCOLS 65 RICHARD A. GUARINO INTRODUCTION
65 STUDY OBJECTIVE 66 GENERAL CONSIDERATIONS IN PROTOCOL DESIGN 67
DIFFERENT STUDY DESIGNS 67 ELEMENTS OF A PROTOCOL: A CHECKLIST 72
SUMMARY 93 BIBLIOGRAPHY 93 CONTENTS IX 4 CLINICAL DEVELOPMENT OF OTC
DRUGS 97 BERNARD P. SCHACHTEL INTRODUCTION 97 OTC DRUG DEVELOPMENT
THROUGH THE NDA PROCESS 98 THE DIFFERENCES IN OTC RESEARCH 101 THE
R-TO-OTC SWITCH 103 CONCLUSION 103 REFERENCES 104 STATISTICAL AND DATA
MANAGEMENT COLLABORATION IN CLINICAL RESEARCH 105 GUY M. COHEN
INTRODUCTION 105 THE FDA GUIDELINES 107 THE FIRST CLINICAL TRIALS 107
PROTOCOL DESIGN 109 RISK AND TARGETING A TREATMENT POPULATION 111 THE
STUDY DESIGN 113 SOME BASICS OF STATISTICS 119 THE STATISTICAL STATEMENT
121 THE DESIGN OF METHODS AND THE FDA 122 CLINICAL STUDY EXECUTION 123
INTERIM ANALYSES 125 OVERVIEW OF CLINICAL STUDY DATA ANALYSIS 126 FINAL
STUDY REPORTS 127 CONCLUSION 131 BIBLIOGRAPHY 132 BIOTECHNOLOGY: EL AS
AND PL AS , 133 JAMES J. CONKLIN INTRODUCTION 133 REGULATION OF
BIOTECHNOLOGY 134 CLINICAL TRIALS OF BIOTECHNOLOGY PRODUCTS 141 CONTENTS
RELATIONSHIP BETWEEN MANUFACTURING AND BIOTECHNOLOGY CLINICAL TRIALS 143
CONCLUSION 144 REFERENCES 144 7 IMAGE PROCESSING TECHNIQUES APPLIED TO
DRUG AND MEDICAL DEVICE DEVELOPMENT 145 JAMES J. CONKLIN, HARRY L.
LOATS, ANDREW S. LOATS INTRODUCTION IMAGE ANALYSIS AND SYSTEM
DESCRIPTION BIOSTATISTICAL CONSIDERATIONS EXAMPLES OF QUANTITATIVE IMAGE
PROCESSING IN DRUG DEVELOPMENT CONCLUSION REFERENCES 145 146 147 149 153
153 8 INDUSTRY AND FDA LIAISON 155 WILLIAM M. TROETEL INTRODUCTION 155
THE FDA ORGANIZATION 155 FDA/INDUSTRY MEETINGS 159 THE IND/NDA
CLASSIFICATION SYSTEM 163 PREPARING FOR AN END-OF-PHASE 2 CONFERENCE 165
FDA INITIATIVES TO SPEED DRUG APPROVAL 168
BIOAVAILABILITY/BIOEQUIVALENCE DATA 172 ADVISORY COMMITTEES 174 SUMMARY
175 BIBLIOGRAPHY 176 9 OBLIGATIONS OF INVESTIGATOR, SPONSOR, AND MONITOR
177 RICHARD A. GUARINO CONTENTS XI 10 THE MANAGEMENT OF CLINICAL STUDIES
185 ROBERT MCCORMACK INTRODUCTION 185 HISTORY OF GOOD CLINICAL PRACTICES
186 THE CLINICAL DEVELOPMENT PLAN 188 INDIVIDUAL STUDY DESIGN 188
INVESTIGATOR SELECTION 189 THE PREINVESTIGATIONAL SITE VISIT 189 THE
STUDY INITIATION VISIT 192 MONITORING A STUDY 194 CLINICAL STUDY CLOSURE
199 SUMMARY 200 REFERENCE 201 11 ADVERSE REACTIONS AND INTERACTIONS OF
DRUGS 203 RICHARD A. GUARINO, R. DORRIEN VENN INTRODUCTION
CLASSIFICATION OF ADVERSE DRUG REACTIONS DOSE-DEPENDENT ADVERSE
REACTIONS DOSE-INDEPENDENT ADVERSE REACTIONS DRUG INTERACTIONS
COLLECTION AND EVALUATION OF ADVERSE REACTIONS TO DRUGS SUMMARY
REFERENCES ; 203 204 204 209 210 215 221 221 12 INSTITUTIONAL REVIEW
BOARDS, INFORMED CONSENT, AND AUDITING 225 THOMAS J. HYNDS INTRODUCTION
225 THE INSTITUTIONAL REVIEW BOARD 225 SEEKING IRB REVIEW AND APPROVAL
OF A CLINICAL STUDY 231 XII CONTENTS THE INFORMED CONSENT FORM 231
AUDITING 235 BIBLIOGRAPHY 242 13 GENERAL CONSIDERATIONS OF THE NDA 243
ANDREW G. CLAIR, LLOYD G. MILLSTEIN INTRODUCTION 243 DEFINITIONS 244
CLINICAL RESEARCH DATA FROM FOREIGN COUNTRIES 248 GENERAL REQUIREMENTS
249 NDA REGULATIONS 256 NDA DAY 259 NDA REVIEW TIMES 260 COMPUTER
ASSISTED NEW DRUG APPLICATION (CANDA) 261 HOW TO IMPROVE NDA HANDLING
262 APPLICABLE NDA REGULATIONS 263 REFERENCES 263 14 SPECIFIC
REQUIREMENTS, CONTENT, AND FORMAT OF AN NDA 265 AILEEN RYAN, MARK
CALCAMUGGIO INTRODUCTION 265 CONTENT AND FORMAT OF AN APPLICATION 265
FORMATTING, ASSEMBLING, AND SUBMITTING NEW DRUG AND ANTIBIOTIC
APPLICATIONS 266 NDA SUMMARY FORMAT AND CONTENT 272 NDA TECHNICAL
SECTIONS 283 THE ABBREVIATED NEW DRUG APPLICATION (ANDA) 316 SUMMARY 317
APPENDIX A. NDA REVIEW GUIDE 317 APPENDIX B. DATA FOR THE NDA 319
REFERENCES 319 CONTENTS XIII 15 MANUFACTURING AND CONTROL REQUIREMENTS
OF THE NDA AND ANDA 325 M. DOUGLAS WINSHIP, ROBERT MCCORMACK
INTRODUCTION 325 THE NDA SUMMARY 327 CHEMISTRY, MANUFACTURING, AND
CONTROLS SECTION 330 ABBREVIATED NEW DRUG APPLICATION (ANDA) 352
CONCLUSION 354 BIBLIOGRAPHY 355 16 DRUG PRODUCT LABELING 357 LLOYD G.
MILLSTEIN INTRODUCTION 357 BACKGROUND 357 DEFINITIONS 360 GENERAL
REQUIREMENTS 361 LABELING REGULATIONS FOR PRESCRIPTION DRUGS 361
SPECIFIC REQUIREMENTS 364 CLASS LABELING AND VOLUNTARY SECTIONS 384
PATIENT LABELING 387 SUMMARY 390 APPENDIX A. SPECIFIC LABELING
REQUIREMENTS FOR SPECIFIC DRUGS 391 APPENDIX B. SUMMARY OF THE SPECIFIC
REQUIREMENTS ON CONTENTS AND FORMAT OF LABELING * FOR HUMAN PRESCRIPTION
DRUGS 396 REFERENCES 398 17 DRUGS FOR SERIOUS, LIFE-THREATENING
DISEASES: A SPECIAL FDA LIAISON 401 ANDREW G. CLAIR INTRODUCTION 401
TREATMENT INDS 405 XIV CONTENTS RISK-BENEFIT 407 POST-MARKETING
SURVEILLANCE 407 PROGRAM SCOPE 407 REFERENCES 411 18 REGULATIONS FOR OTC
DRUGS 413 WILLIAM E. GILBERTSON INTRODUCTION 413 BACKGROUND 413 THE OTC
PROBLEM 414 MONOGRAPH GENERAL PROVISIONS 417 MONOGRAPH ACTIVE
INGREDIENTS 417 MONOGRAPH LABELING 418 MONOGRAPH TESTING 420 THE
NONMONOGRAPH 420 THE R-TO-OTC SWITCH 421 RECLASSIFICATION 422
CONSIDERATIONS IN REVIEW 423 PUBLIC ATTITUDES 423 EXAMPLE - RULEMAKING
AUTHORITY 424 EXAMPLE - NDA SUBMISSION 424 CONCLUSION 425 19 ABBREVIATED
AND SUPPLEMENTAL NEW DRUG APPLICATIONS 427 WILLIAM M. TROETEL
INTRODUCTION 427 THE ANDA*A BRIEF HISTORICAL PERSPECTIVE 427 ANDA
REQUIREMENTS 432 SUPPLEMENTAL NEW DRUG APPLICATIONS 439 SUMMARY 444
REFERENCES 446 BIBLIOGRAPHY 446 CONTENTS XV 20 THE ORPHAN DRUG 447
AILEEN RYAN INTRODUCTION 447 THE ORPHAN DRUG ACT 448 REQUEST FOR ORPHAN
DRUG DESIGNATION 451 OTHER CONSIDERATIONS 454 PROPOSED ORPHAN DRUG
REGULATIONS 455 CONCLUSION 458 APPENDIX A. SUGGESTED FORMATS FOR
SUBMISSION OF MATERIAL FOR FINANCIAL COSTS (EXAMPLE 1) 459 APPENDIX B.
SUGGESTED FORMATS FOR SUBMISSION OF MATERIAL FOR FINANCIAL COSTS
(EXAMPLE 2) 460 BIBLIOGRAPHY 461 INDEX 463
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| id | DE-604.BV006627425 |
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| indexdate | 2024-07-09T16:49:30Z |
| institution | BVB |
| isbn | 082478801X |
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| series | Drugs and the pharmaceutical sciences |
| series2 | Drugs and the pharmaceutical sciences |
| spelling | New drug approval process ed. by Richard A. Guarino 2. ed., rev. and expanded New York [u.a.] Dekker 1993 XV, 469 S. txt rdacontent n rdamedia nc rdacarrier Drugs and the pharmaceutical sciences 30 Médicaments - Essais cliniques - Normes Médicaments - Essais cliniques - Politique gouvernementale - États-Unis Produits nouveaux - Politique gouvernementale - États-Unis Politik Clinical Trials as Topic standards United States Drug Evaluation standards United States Drug approval United States Drugs Testing Government policy United States Drugs Testing Standards New products Government policy United States Richtlinie (DE-588)4137814-3 gnd rswk-swf Arzneimittelprüfung (DE-588)4128030-1 gnd rswk-swf Zulassung (DE-588)4127410-6 gnd rswk-swf Arzneimittel (DE-588)4003115-9 gnd rswk-swf USA USA (DE-588)4078704-7 gnd rswk-swf 1\p (DE-588)4143413-4 Aufsatzsammlung gnd-content USA (DE-588)4078704-7 g Arzneimittelprüfung (DE-588)4128030-1 s Richtlinie (DE-588)4137814-3 s DE-604 Arzneimittel (DE-588)4003115-9 s Zulassung (DE-588)4127410-6 s 2\p DE-604 Guarino, Richard A. 1935- Sonstige (DE-588)139424458 oth Drugs and the pharmaceutical sciences 30 (DE-604)BV000002008 30 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=004235962&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk 2\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | New drug approval process Drugs and the pharmaceutical sciences Médicaments - Essais cliniques - Normes Médicaments - Essais cliniques - Politique gouvernementale - États-Unis Produits nouveaux - Politique gouvernementale - États-Unis Politik Clinical Trials as Topic standards United States Drug Evaluation standards United States Drug approval United States Drugs Testing Government policy United States Drugs Testing Standards New products Government policy United States Richtlinie (DE-588)4137814-3 gnd Arzneimittelprüfung (DE-588)4128030-1 gnd Zulassung (DE-588)4127410-6 gnd Arzneimittel (DE-588)4003115-9 gnd |
| subject_GND | (DE-588)4137814-3 (DE-588)4128030-1 (DE-588)4127410-6 (DE-588)4003115-9 (DE-588)4078704-7 (DE-588)4143413-4 |
| title | New drug approval process |
| title_auth | New drug approval process |
| title_exact_search | New drug approval process |
| title_full | New drug approval process ed. by Richard A. Guarino |
| title_fullStr | New drug approval process ed. by Richard A. Guarino |
| title_full_unstemmed | New drug approval process ed. by Richard A. Guarino |
| title_short | New drug approval process |
| title_sort | new drug approval process |
| topic | Médicaments - Essais cliniques - Normes Médicaments - Essais cliniques - Politique gouvernementale - États-Unis Produits nouveaux - Politique gouvernementale - États-Unis Politik Clinical Trials as Topic standards United States Drug Evaluation standards United States Drug approval United States Drugs Testing Government policy United States Drugs Testing Standards New products Government policy United States Richtlinie (DE-588)4137814-3 gnd Arzneimittelprüfung (DE-588)4128030-1 gnd Zulassung (DE-588)4127410-6 gnd Arzneimittel (DE-588)4003115-9 gnd |
| topic_facet | Médicaments - Essais cliniques - Normes Médicaments - Essais cliniques - Politique gouvernementale - États-Unis Produits nouveaux - Politique gouvernementale - États-Unis Politik Clinical Trials as Topic standards United States Drug Evaluation standards United States Drug approval United States Drugs Testing Government policy United States Drugs Testing Standards New products Government policy United States Richtlinie Arzneimittelprüfung Zulassung Arzneimittel USA Aufsatzsammlung |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=004235962&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV000002008 |
| work_keys_str_mv | AT guarinoricharda newdrugapprovalprocess |