Managing the clinical drug development process:
Saved in:
| Main Authors: | , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York u.a.
Dekker
1992
|
| Series: | Drugs and the pharmaceutical sciences
51 |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | XIV, 217 S. |
| ISBN: | 0824785959 |
Staff View
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Record in the Search Index
| _version_ | 1804118904517165056 |
|---|---|
| adam_text | MANAEIIG TOE CLINICAL DRAG DEVELOPMENI PROCESS DAVID M. COCCHETTO GLAXO
INC. RESEARCH TRIANGLE PARK, NORTH CAROLINA RONALD V. NARDI PARKE-DAVIS
PHARMACEUTICAL RESEARCH DIVISION WARNER-LAMBERT COMPANY ANN ARBOR.
MICHIGAN MARCEL DEKKER, INC. NEW YORK * BASEL * HONG KONG CONTENTS
PREFACE V PART ONE INTRODUCTION TO CLINICAL DRUG DEVELOPMENT 1. BASIC
CONCEPTS OF CLINICAL DRUG DEVELOPMENT 3 I. INTRODUCTION 3 II. WHY DRUGS
FAIL TO ATTAIN APPROVAL 4 III. PREREQUISITES TO SUCCESSFUL CLINICAL DRUG
DEVELOPMENT 4 IV. ODDS OF SUCCESSFUL DRUG DEVELOPMENT 8 V. CHOOSING NEW
CHEMICAL ENTITIES FOR DEVELOPMENT IN THE RESEARCH-BASED PHARMACEUTICAL
INDUSTRY 9 REFERENCES 14 PART TWO APPROACHES TO CLINICAL DRUG
DEVELOPMENT 2. PURPOSE OF CLINICAL DRUG DEVELOPMENT: ASSESSMENT OF
BENEFITS AND RISKS 17 I. INTRODUCTION 17 II. BENEFIT/RISK ASSESSMENT 18
A. ACUTE DISEASE 19 B. EPISODIC DISEASE 20 C. CHRONIC DISEASE 21 1.
HYPERTENSION 23 2. CONGESTIVE HEART FAILURE 24 3. RHEUMATOID ARTHRITIS
24 IX ( CONTENTS III. APPROACHES TO BENEFIT/RISK ASSESSMENT 24 A.
METHODS OF CLINICAL SAFETY ASSESSMENT 25 B. METHODS OF LABORATORY SAFETY
ASSESSMENT 29 IV. SUMMARY OF CURRENT APPROACHES 29 REFERENCES 32 3.
LIMITATIONS OF CONVENTIONAL METHODS AND ALTERNATIVE APPROACHES TO
BENEFIT/RISK ASSESSMENT 41 I. LIMITATIONS OF CONVENTIONAL METHODS 41 II.
TWO ISSUES IN SAFETY ASSESSMENT 43 III. REASONS FOR INADEQUACIES OF
SAFETY PROFILES 44 IV. ALTERNATIVE APPROACHES 45 A. INTEGRATED SUMMARY
OF SAFETY 45 B. STUDIES IN PATIENT SUBPOPULATIONS AT HIGHER RISK 45 C.
STUDIES DESIGNED SPECIFICALLY TO ASSESS SAFETY 48 D. SUMMARY OF
ALTERNATIVE APPROACHES 49 REFERENCES 49 4. PRINCIPLES OF DOSE-RESPONSE
RELATIONSHIPS WITH APPLICATION TO CLINICAL DRUG DEVELOPMENT 53 I.
INTRODUCTION 53 A. THE PHASES OF CLINICAL DRUG DEVELOPMENT 53 B. THE
DOSE-RESPONSE PERSPECTIVE IN DRUG DEVELOPMENT 54 II. INVESTIGATIONAL
DOSE RANGE 56 A. DEFINITION AND IMPORTANCE 56 B. SOME PRACTICAL
CONSIDERATIONS 58 III. THERAPEUTIC DOSE RANGE 59 A. DEFINITION AND
IMPORTANCE 59 B. LIMITING THE MAXIMUM THERAPEUTIC DOSE 61 C.
CHARACTERIZATION OF MINIMUM EFFECTIVE DOSE 61 D. CONSERVATIVE SELECTION
OF THERAPEUTIC DOSE RANGE 62 IV. STEADY-STATE CHARACTERIZATION OF
THERAPEUTIC DOSE RANGE 62 V. OPTIMAL BENEFIT/RISK PROFILE 63 VI.
POPULATION VARIABILITY 64 VII. SUMMARY 65 REFERENCES 66 5. THE SLIDING
SCALE OF BENEFIT/RISK ASSESSMENT 68 I. INTRODUCTION 68 II. SLIDING SCALE
OF DISEASE-DICTATED BENEFIT AND RISK 69 A. ACUTE DISEASE 70 1.
MYOCARDIAL INFARCTION 70 2. THE COMMON COLD 71 B. CHRONIC DISEASE 71 1.
PARKINSON S DISEASE 72 2. GASTROESOPHAGEAL REFLUX DISEASE 72 3. FINAL
CONSIDERATIONS FOR CHRONIC DISEASE 73 CONTENTS XI III. SLIDING SCALE FOR
DIFFERENT PATIENT SUBPOPULATIONS 74 A. HYPERTENSION 75 1. SUBPOPULATIONS
OF PATIENTS 75 2. PATHOLOGICAL HYPERTENSION VERSUS INCIDENTAL
HYPERTENSION 76 3. CONSIDERATIONS FOR STUDIES OF ANTIHYPERTENSIVE DRUGS
77 B. GASTROESOPHAGEAL REFLUX DISEASE 78 C. THROMBOLYTIC THERAPY FOR
MYOCARDIAL INFARCTION 80 D. NSAID-INDUCED ULCERS 81 IV. TREATMENT
FAILURES 81 V. SUMMARY 82 REFERENCES 82 6. TREATMENT USE OF
INVESTIGATIONAL DRUGS: A SPECIAL SETTING FOR BENEFIT/RISK ASSESSMENT 84
I. INTRODUCTION 84 II. REGULATORY CONSIDERATIONS FOR A TREATMENT IND 85
III. SUBPART E DESIGNATION 88 IV. EMERGENCY (COMPASSIONATE) USE 89 V.
ADDITIONAL METHODS FOR TREATMENT USE OF INVESTIGATIONAL DRUGS 92 A.
PARALLEL TRACK MECHANISM 92 B. IMPORTATION OF UNAPPROVED DRUGS FOR
PERSONAL USE 92 VI. CONSIDERATIONS IN THE DECISION TO PURSUE TREATMENT
USE OF AN INVESTIGATIONAL DRUG 92 VII. INVESTIGATOR AND SPONSOR
RESPONSIBILITIES 94 VIII. SUMMARY 96 REFERENCES 97 PART THREE ISSUES IN
MANAGING CLINICAL DRUG DEVELOPMENT 7. MAINTENANCE OF CONTINUITY 101 I.
INTRODUCTION 101 II. THE CONCEPT OF RESEARCH MENTALITY 103 III. RESEARCH
MENTALITY AND DRUG DEVELOPMENT 106 A. CONTRAST IN RESEARCH MENTALITIES
OF BASIC RESEARCH VERSUS CLINICAL RESEARCH 106 B. NEED FOR A COLLECTIVE
RESEARCH MENTALITY IN CLINICAL RESEARCH 107 IV. PERTURBATIONS OF
RESEARCH MENTALITY 108 A. SCIENCE-BASED PERTURBATIONS 109 B.
PERSONNEL-BASED PERTURBATIONS 109 C. MARKETING-BASED PERTURBATIONS 112
D. REGULATION-BASED PERTURBATIONS 113 XII CONTENTS V. MEASURES TO
PREVENT AND COUNTERACT BREECHES IN RESEARCH MENTALITY 115 A. PROJECT
TEAMS 115 B. BREAKS IN RESEARCH MENTALITY AT THE TIME OF APPROVAL 118
VI. SUMMARY 118 REFERENCES 121 8. PROJECT MANAGEMENT SYSTEMS TO
ESTABLISH CONTINUITY AND CRITICAL MASS 123 I. INTRODUCTION 123 II.
HISTORICAL PERSPECTIVE ON DRUG DEVELOPMENT 124 III. THREE TYPES OF
PROJECT MANAGEMENT 126 IV. WHY IS CRITICAL MASS ESSENTIAL? 131 V.
RESEARCH EQUITY 133 VI. ADAPTATIONS IN PROJECT MANAGEMENT TO INCORPORATE
CRITICAL MASS 134 VII. OBSTACLES TO FORMATION OF CRITICAL MASS PROJECT
TEAMS 135 VIII. SUMMARY 138 REFERENCES 140 9. RESOURCE-LIMITED VERSUS
INTELLECT-LIMITED PROJECTS 142 I. INTRODUCTION 142 II. CHARACTERISTICS
OF RESOURCE-LIMITED VERSUS INTELLECT-LIMITED PROJECTS 143 III.
CONSIDERATIONS FOR MANAGING INTELLECT-LIMITED PROJECTS 145 10.
INTERACTIONS BETWEEN CLINICAL RESEARCH AND MARKETING GROUPS 148 I.
INTRODUCTION 148 II. MARKET-PUSH VERSUS RESEARCH-PULL AS THE BASIS OF
INNOVATION 149 III. INTERACTION BETWEEN RESEARCH AND MARKETING 152 IV.
SCOPE OF DISCOVERY RESEARCH: BROAD OR FOCUSED? 154 V. ESTABLISHING A
CONTEXT FOR PRODUCT LICENSURE 157 REFERENCES 159 PART FOUR THE PAST, THE
PRESENT, AND THE FUTURE OF CLINICAL DRUG DEVELOPMENT 11. THE PAST: MAJOR
LAWS GOVERNING CLINICAL DRUG DEVELOPMENT IN THE UNITED STATES 163 I.
INTRODUCTION 163 II. THE BEGINNINGS OF PHARMACEUTICAL LAW 163 III.
PHARMACOPOEIAS AS A MEANS TO SET STANDARDS FOR DRUG PRODUCTS 165 IV.
EARLY FEDERAL LEGISLATION 165 V. FEDERAL FOOD, DRUG AND COSMETIC ACT 171
CONTENTS XIII VI. AMENDMENTS TO THE FD&C ACT 172 A. BATCH CERTIFICATION
OF INSULIN AND PENICILLIN 172 B. MILLER AMENDMENT AND DURHAM-HUMPHREY
AMENDMENT 173 C. KEFAUVER-HARRIS AMENDMENTS 175 VII. THE DESI PROJECT
178 VIII. ANDA, PAPER NDA, AND OTHER MEANS FOR GENERIC PRODUCTS TO ENTER
THE PHARMACEUTICAL MARKET 179 A. ANDAS AND PAPER NDAS 180 B. DRUG PRICE
COMPETITION AND PATENT TERM RESTORATION ACT (WAXMAN-HATCH AMENDMENTS)
183 1. HISTORY OF DPC-PTR ACT 183 2. DPC-PTR PROVISIONS FOR ANDAS AND
PAPER NDAS 185 3. DPC-PTR PROVISIONS FOR PATENT EXTENSION 186 4. DPC-PTR
PROVISIONS FOR MARKET EXCLUSIVITY 187 5. IMPLICATIONS OF THE DPC-PTR ACT
, 188 IX. OTHER MAJOR LEGISLATION 188 X. SUMMARY 190 REFERENCES 191 12.
THE PRESENT: CURRENT TRENDS AND CONTROVERSIES 194 I. INTRODUCTION 194
II. INDUSTRIAL CONSOLIDATION 194 III. INTERNATIONAL USES OF CLINICAL
TRIAL DATA 195 IV. CONTRACT RESEARCH ORGANIZATIONS 197 V. R&D
PRODUCTIVITY 198 VI. OPERATING TRENDS AT FDA 198 VII. GENERIC DRUGS 199
VIII. SHIFTING NATURE OF PATIENT POPULATIONS 199 IX. DEMONSTRATING
IMPROVED QUALITY OF LIFE AS A PRECURSOR TO DRUG APPROVAL 200 REFERENCES
201 13. THE FUTURE OF CLINICAL DRUG DEVELOPMENT 203 I. INTRODUCTION 203
II. REGULATORY ENVIRONMENT 204 A. DISCERNING DRUGS THAT ARE POTENTIALLY
APPROVABLE 204 B. APPLICABILITY OF THE NDA DATA TO THE POST-APPROVAL
PATIENT POPULATION 205 C. MORE SPECIFIC VERSUS MORE GENERAL REGULATIONS
AND GUIDELINES 206 D. FUTURE REGULATORY ENVIRONMENT 207 III. CORPORATE
ENVIRONMENT 208 A. CORPORATE STRATEGIES FROM VIEWING DRUG DEVELOPMENT AS
A SERIES OF REGULATORY HURDLES 208 B. INNOVATIVE DRUG DISCOVERY IN
CORPORATIONS 210 XIV CONTENTS IV. OPPORTUNITIES 210 A. THE CONTRARIAN
STRATEGY 210 B. MAXIMUM VALUE FROM THE RESEARCH INFORMATION BASE 211 C.
IDENTIFICATION OF NEW THERAPEUTIC TARGETS 211 D. IMPROVEMENT OF QUALITY
213 V. THE THREE FACES OF THE FUTURE 213 INDEX 215
|
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| physical | XIV, 217 S. |
| publishDate | 1992 |
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| series | Drugs and the pharmaceutical sciences |
| series2 | Drugs and the pharmaceutical sciences |
| spelling | Cocchetto, David M. Verfasser aut Managing the clinical drug development process David M. Cocchetto ; Ronald V. Nardi New York u.a. Dekker 1992 XIV, 217 S. txt rdacontent n rdamedia nc rdacarrier Drugs and the pharmaceutical sciences 51 Médicaments - Efficacité - Évaluation Médicaments - Essais cliniques Médicaments - Recherche - Gestion Clinical Trials as Topic Drug Industry organization & administration Drug development Management Drugs Effectiveness Evaluation Drugs Research Management Klinische Prüfung (DE-588)4031192-2 gnd rswk-swf Klinische Prüfung (DE-588)4031192-2 s DE-604 Nardi, Ronald V. Verfasser aut Drugs and the pharmaceutical sciences 51 (DE-604)BV000002008 51 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=002947523&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Cocchetto, David M. Nardi, Ronald V. Managing the clinical drug development process Drugs and the pharmaceutical sciences Médicaments - Efficacité - Évaluation Médicaments - Essais cliniques Médicaments - Recherche - Gestion Clinical Trials as Topic Drug Industry organization & administration Drug development Management Drugs Effectiveness Evaluation Drugs Research Management Klinische Prüfung (DE-588)4031192-2 gnd |
| subject_GND | (DE-588)4031192-2 |
| title | Managing the clinical drug development process |
| title_auth | Managing the clinical drug development process |
| title_exact_search | Managing the clinical drug development process |
| title_full | Managing the clinical drug development process David M. Cocchetto ; Ronald V. Nardi |
| title_fullStr | Managing the clinical drug development process David M. Cocchetto ; Ronald V. Nardi |
| title_full_unstemmed | Managing the clinical drug development process David M. Cocchetto ; Ronald V. Nardi |
| title_short | Managing the clinical drug development process |
| title_sort | managing the clinical drug development process |
| topic | Médicaments - Efficacité - Évaluation Médicaments - Essais cliniques Médicaments - Recherche - Gestion Clinical Trials as Topic Drug Industry organization & administration Drug development Management Drugs Effectiveness Evaluation Drugs Research Management Klinische Prüfung (DE-588)4031192-2 gnd |
| topic_facet | Médicaments - Efficacité - Évaluation Médicaments - Essais cliniques Médicaments - Recherche - Gestion Clinical Trials as Topic Drug Industry organization & administration Drug development Management Drugs Effectiveness Evaluation Drugs Research Management Klinische Prüfung |
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