Table of Contents
Preface iii
Contributors xiii
1 Introduction: The Drug Discovery and Development Process Josée Schepper 1
Introduction 1
The Development of New Drugs in a Basic Research Environment 2
Target Identification and Validation 3
Lead Generation 3
Lead Optimization 4
Preclinical Development 4
Clinical Development 4
Marketing 5
Associations 5
Journals 6
Web Sites 8
References 9
Further Reading 10
2 Chemistry Josée Schepper 11
Lead Generation 12
High-Throughput Screening 13
Lead Modification 14
Structure-Activity Relationship (SAR) Studies 14
Future 16
Associations 16
Abstracts and Indexes 18
Journals 20
Web Sites 24
Reference 24
Further Reading 25
3 Genomics, Proteomics, and Bioinformatics Mary Chitty 27
Introduction 27
Genomics 28
Proteomics 29
Bioinformatics 29
Chemistry 30
Pharmacogenomics 30
Toxicogenomics 31
Systems Biology 31
Predictive and Molecular Medicine 32
Biotechnology Associations 32
Biotechnology Government Organizations 33
Genomic and Proteomic Associations 34
Genomic and Proteomics Government Organizations 35
Bioinformatics Associations 36
Bioinformatics Government Agencies 37
Cheminformatics Associations 37
Cheminformatics Government Organizations 38
Pharmacogenomics Associations 38
Toxicogenomics Associations 38
Toxicogenomics Government Organizations 39
Current Awareness and News 39
Bibliographies 40
Directories 40
Handbooks 41
Methods and Protocols 41
Key Biopharmaceutical Journals 42
Genomics and Proteomics Journals 43
Bioinformatics Journals 46
Chemogenomics Journals 46
Cheminformatics Journals 47
Drug Discovery and Development Journals 48
Pharmacogenomics Journals 50
Toxicogenomics Journal 50
Molecular Medicine Journals 50
Database Directories 52
Genomic and Proteomic Databases 52
Comparative and Functional Genomics Databases 53
Chemical Genomics Databases 55
Pharmacogenomics Databases 55
Toxicogenomics Databases 56
Software 57
Reference 57
4 Toxicology Tara M. Breton Sharon Srodin 59
Introduction 59
Associations 61
Databases 63
Journals 65
Reference Works 70
Regulatory Guidelines and Other Documents 73
5 Pharmacology Sharon Srodin Josée Schepper 75
Introduction 75
Associations 77
Abstracts and Indexes 80
Journals 83
Reference Books 85
Regulatory Guidance 87
Web Sites 88
6 Drug Regulation Bonnie Snow 91
Introduction 91
Sources of Information Regarding New Drug Approvals 93
Postmarketing Safety Surveillance: Pharmacovigilance and Product Recall Information Sources 117
Information Sources Related to Quality Assurance and Compliance 120
Other Key Sources of Regulatory Intelligence 127
7 Sales and Marketing Sharon Srodin 135
Introduction 135
Associations 137
Clinical Literature 140
Evidence-Based Medicine 145
Regulatory Guidance 146
Statistical Data: Demographics, Incidence, Prevalence, and Sales 148
Syndicated Market Research 151
Trade and Nonclinical Literature 160
8 Competitive Intelligence Lisa A. Hayes 167
Associations 169
Drug Pipelines 170
Company Profiles 173
Financial Data 176
Alliances and In-Licensing 179
News 181
9 Pharmacoeconomics Tamara Gilberto 187
Introduction 187
Databases 189
Web Sites 190
Online Tutorials 192
Reports 192
Journals 194
Books 195
Glossary (1) 195
Reference 196
10 Intellectual Property Edlyn S. Simmons 197
Introduction 197
Further Reading on Intellectual Property 199
Trademarks 201
Trademark Databases 203
Patents 205
Anatomy of a Patent Document 207
Further Reading on Markush Structures 210
Patent Law 210
Further Reading on Patent Law 214
Patent Searches 215
Further Reading on Patent Searching 217
Patent Databases 219
Patent Office and Country Databases 219
Commercial Patent Databases 222
Further Reading on Commercial Patent Databases 230
Pipeline Databases with Patent Information 231
Reference 231
11 Medical Devices and Combination Products Beth White 233
Introduction 233
Device Regulation 238
Sources of Regulatory Information 243
Medical Technology 248
Medical Device Industry and Competitive Intelligence 279
Subject Index 299
Resource Index 305