List of Figures p. ix
Preface p. xi
Guide to the Guide p. 1
Prospective Users and Practical Applications p. 1
Three Different Approaches to Using the Guide's Content p. 2
Scope p. 4
Reference Format and Annotation Content p. 4
Beware: No Single Source Is Comprehensive p. 8
Drug Identification: Variations in Drug Nomenclature and Their Impact on Information Retrieval p. 9
Types of Drug Names p. 11
Chemical Name p. 11
Chemical Abstracts Service Registry Number (CAS RN) p. 12
Laboratory Code, Research Number, or Investigational Drug Number p. 13
Nonproprietary or Generic Name p. 13
Brand, Proprietary, Trade, or "Trivial" Name p. 15
Drug Classification p. 15
Pharmacological Action p. 16
Therapeutic/Diagnostic Use p. 16
Chemical Derivation or Affiliation p. 16
Less Frequently Used Identifiers p. 18
Molecular or Empirical Formula p. 18
Chemical Structure, Structural Formula p. 18
Enzyme Commission Number p. 19
National Drug Code p. 19
Other Nomenclature Issues p. 20
Synthetic versus "Natural" p. 20
Prescription versus Over-the-Counter p. 20
"Ethical" as a Marketing Term p. 21
"Generic" as a Marketing Term p. 21
Drug Identification and Nomenclature Sources p. 22
Official Compendia p. 23
Commercial Sources p. 28
Additional Nomenclature Sources Integrated into Online Search Systems p. 33
Drug Identification from Description or Observation of a Dosage Form p. 35
FDA Regulation of Imprints p. 36
Factors to Consider When Evaluating "Physical ID" Resources p. 37
Physical ID Guides Incorporated into Drug Compendia p. 40
References p. 42
Additional Sources of Information p. 42
Government Regulations Affecting Drugs and the Pharmaceutical Industry p. 45
The New Drug Development and Approval Process in the United States p. 46
Historical Background p. 46
Preapproval Requirements p. 48
Access to Regulatory Information Prior to NDA/BLA Approval p. 59
Sources for Product Approvals and Basis-of-Approval Documents p. 59
U.S. Regulation of Over-the-Counter Product Introductions p. 63
The New Drug Registration Process in Europe p. 69
Historical Background p. 69
Marketing Authorization Applications for New Drugs and Biologics p. 70
EU Product Approvals and Basis-of-Approval Documents p. 72
EU Regulation of Over-the-Counter Product Introductions and Herbal Medications p. 77
Generic Drugs p. 80
U.S. Regulation of Generic Drugs p. 81
Market Exclusivity Provisions in U.S. Law p. 82
Verifying U.S. Patent Term Extensions and Tracking Applications for "Restoration Days" p. 88
Regulation of Generic Drugs in the European Union p. 91
EU Provisions for Market Exclusivity p. 94
Answering Questions about EU Marketing Exclusivity and Patent or SPC Expiration p. 97
Verifying Producers of Active Pharmaceutical Ingredients: DMFs and CEPs p. 102
Regulatory Incentives to Encourage Innovation and Reduce "Drug Lag" p. 103
Orphan Drug Laws p. 104
Incentive Programs for Pediatric Drugs p. 108
Providing Patients Access to Investigational Drugs Prior to Approval p. 111
Measures to Expedite the Regulatory Review Process p. 114
International Cooperative Efforts: ICH and the Pharmacopeial Discussion Group p. 123
Phase IV Postmarketing Studies p. 126
Government Programs to Ensure Drug Safety p. 129
Risk Management Strategies p. 131
Restricted Access Programs: Scheduled Drugs p. 133
Hazard Communication Standards and MSDS p. 138
Documents Associated with Quality Assurance and Compliance p. 139
Regulations p. 140
Guidelines p. 142
GMP Compliance Policy Guides and Inspection References p. 143
Warning Letters p. 146
Product Recalls, Seizures, or Withdrawals p. 148
Commercial Regulatory Information Systems, Current Awareness Sources, and Free Web Directories p. 151
Current Awareness Sources p. 153
Specialized Web Directories and Pathfinder Sites p. 156
Laws Governing the Practice of Pharmacy p. 158
References p. 162
Additional Sources of Information p. 164
Evaluating Drug Information Sources and Developing a Search Protocol p. 165
Structure and Organization of the Literature: Scaling the Pyramid p. 167
Source Evaluation Checklist p. 169
Documentation and Credibility p. 171
Guides to the Literature p. 172
Internet Pathfinders p. 177
References p. 181
Additional Sources of Information p. 181
Pharmacology and Therapeutics Reference Sources p. 183
Core Collection for Access to U.S. Pharmacotherapeutic Information p. 183
Alternative Selections and Additional Bibliography p. 190
Handbooks p. 192
Encyclopedic Works and Textbooks p. 193
Free Pharmacotherapeutic Ready-Reference Sources on the Internet p. 195
Guides to Nonprescription Drugs and Dietary Supplements p. 198
Reference Sources for Herbal Preparations, Phytopharmaceuticals, and Other "Natural" Drugs p. 201
Product Guides and Prescribing Information in the Global Marketplace p. 209
Preparing to Answer Foreign Drug Identification and Equivalency Inquiries p. 210
Historical and Commercial Trends Influence Resource Selection p. 211
Veterinary Drugs p. 218
References p. 223
Additional Sources of Information p. 224
Reference Sources for Adverse Drug Reactions and Interactions p. 227
Adverse Reactions Information Sources p. 229
Ready-Reference Sources for Drug Interactions p. 233
Parenteral Incompatibilities p. 238
Specialized Adverse Effects Publications p. 240
Food-Drug Interactions p. 242
Drug Effects on Pregnancy, Lactation, and Reproduction p. 243
Pharmacovigilance Systems: Adverse Event Reports Submitted to Regulatory Authorities p. 248
Online Repositories of Postmarketing Adverse Event Data p. 250
Hazardous Substance Directories p. 258
Material Safety Data Sheets p. 261
References p. 263
Additional Sources of Information p. 265
Drug Analysis, Formulation, and Compounding Reference Sources p. 267
Official Compendial Standards p. 268
Complementary Reference Sourcebooks for Drug Analysis p. 272
Resources to Support Formulation Development p. 274
Additives and Excipients p. 276
Sourcebooks in Pharmaceutical Technology p. 282
Resources to Support Extemporaneous Compounding in the Pharmacy p. 284
References p. 289
Additional Sources of Information p. 289
Compiling Background Bibliography Using Online Resources p. 291
Major Biomedical Databases p. 292
Subject Specialty Indexes to the Bibliography of Pharmacology and Therapeutics p. 302
Complementary Resources p. 307
Influential Factors in Database Selection p. 312
Retrieving References to Routes of Administration p. 313
Isolating Citations to Specific Subject Populations p. 316
Searching Drug Categories p. 317
Finding References to Proprietary Preparations or Brand Name Comparisons p. 321
Filtering Bibliographies by Author Affiliation or Address p. 325
Identifying Publication Types p. 327
Finding References to Conference Papers or Posters p. 328
Free Web Repositories of Meeting Presentations p. 333
Tracking Down Clinical Trial Results Published in Journals p. 333
Databases to Answer Adverse Effects and Interactions Questions p. 336
Retrieving Bibliography on Interactions p. 338
Pharmacovigilance: Searches to Comply with Postmarketing Drug Safety Surveillance Regulations p. 339
Searching for Alternatives to Animal Testing and Related Animal Welfare Bibliography p. 342
Animal Welfare Search Guides and Database Directories p. 346
Pharmaceutics, Pharmaceutical Technology, and Biotechnology Bibliography p. 348
Searches Focused on Drug Delivery p. 350
Online Indexes of Biotechnology Literature p. 353
References p. 354
Additional Sources of Information p. 355
Competitive Intelligence Resources: Drugs-in-Development Directories, Protocol Registries, and Clinical Trial Results Repositories p. 357
Drug Pipeline Databases: Drugs-in-Development Directories p. 357
Key Differences in Pipeline Directories p. 395
Resources for Monitoring Clinical Trials p. 397
The Evolution of Clinical Trial Directories p. 399
Major Protocol Registries or Portals p. 401
Results Repositories and "Trial Tracking" Resources Online p. 408
References p. 420
Additional Sources of Information p. 422
Pharmaceutical Business Intelligence: Companies, Products, and Marketplace Research Sources p. 423
Tracking Pharmaceutical News Online p. 423
Subject Specialty Company Directories Online p. 435
Company Profiles Integrated into Pipeline Search Platforms p. 439
Sources Designed for Monitoring Company Collaborations and Licensing Opportunities p. 442
Surveying the Therapeutic Landscape: Product Directories p. 451
Other Online Sources of Pharmaceutical Market Intelligence p. 453
Syndicated Market Research and Investment Analyst Reports p. 457
Statistical Yearbooks p. 461
References p. 462
Glossary p. 463
Key to Abbreviations and Acronyms p. 495
Index p. 509
About the Author p. 545