How drugs are developed: a practical guide to clinical research
Gespeichert in:
| Beteilige Person: | |
|---|---|
| Format: | Buch |
| Sprache: | Englisch |
| Veröffentlicht: |
Brookwood
Brookwood Medical Publ.
1997
|
| Ausgabe: | 2. ed. |
| Schlagwörter: | |
| Links: | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=007791552&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| Umfang: | IV, 80 S. graph. Darst. |
| ISBN: | 1874409862 |
Internformat
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Datensatz im Suchindex
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|---|---|
| adam_text | CONTENTS
CHAPTER 1. The fundamentals of clinical research 1
INTRODUCTION 1
DRUG DEVELOPMENT AND THE PHARMACEUTICAL INDUSTRY 1
Drug discovery 2
Initial tests 2
First administration to Man Phase I 3
First administration to patients Phase II 3
Risk benefit ratio 4
Difficult decisions 5
Larger scale studies of efficacy and safety Phase HI 5
Application for a product licence 5
Post marketing studies Phase IV 6
Health economics 7
The need for cost effective research 7
THE ELEMENTS OF CLINICAL RESEARCH 8
Patient protection in clinical trials 8
Regulatory aspects 9
The clinical trial protocol 10
Case record forms 11
Trial objectives 13
Controls 14
Trial design 15
Multicentre studies 17
Allocating treatment 18
Blinding 20
Obtaining balanced treatment groups 20
Variability in medicine 21
Placebo 22
Placebo response 22
Using placebo in double blind studies 24
Payment in clinical trials 24
MEASUREMENT IN CLINICAL TRIALS 26
Measuring efficacy 26
Measuring safety 28
Adverse events 29
CHAPTER 2. The critical path of the clinical trial 3£
INTRODUCTION 32
STAGES OF THE CLINICAL TRIAL 34
Planning 34
The study protocol 35
Case record forms 36
Ethics and regulatory affairs 36
Selection of investigators 38
Site assessment and pre study briefing 39
Study materials 39
Patient recruitment 40
Periodic monitoring 42
Study termination 43
Data entry and statistical analysis 43
The Final Report 44
CHAPTER 3. Good clinical practice 46_
INTRODUCTION 46
The need for good clinical practice 46
What is good clinical practice? 47
Harmonisation of GCP? 48
Standard Operating Procedures 50
Responsibilities 50
OUTLINE OF ICH GOOD CLINICAL PRACTICE GUIDELINES 51
Protection of trial subjects and consultation of Ethics Committees 51
Responsibilities 52
Data handling 55
Statistics 56
Quality assurance 57
The Trial Master File 58
Problems of implementing GCP 58
Conclusion 59
CHAPTER 4. Further reading 61_
APPENDICES 63
INDEX 77
|
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| indexdate | 2024-12-20T10:14:55Z |
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| isbn | 1874409862 |
| language | English |
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| spellingShingle | Hutchinson, David R. How drugs are developed a practical guide to clinical research Clinical trials Drugs Testing Pharmaceutical industry Arzneimittelprüfung (DE-588)4128030-1 gnd |
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| title | How drugs are developed a practical guide to clinical research |
| title_auth | How drugs are developed a practical guide to clinical research |
| title_exact_search | How drugs are developed a practical guide to clinical research |
| title_full | How drugs are developed a practical guide to clinical research David R. Hutchinson |
| title_fullStr | How drugs are developed a practical guide to clinical research David R. Hutchinson |
| title_full_unstemmed | How drugs are developed a practical guide to clinical research David R. Hutchinson |
| title_short | How drugs are developed |
| title_sort | how drugs are developed a practical guide to clinical research |
| title_sub | a practical guide to clinical research |
| topic | Clinical trials Drugs Testing Pharmaceutical industry Arzneimittelprüfung (DE-588)4128030-1 gnd |
| topic_facet | Clinical trials Drugs Testing Pharmaceutical industry Arzneimittelprüfung Einführung |
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