Hippa 252

Medical Science Liaisons 252

Medical Communications 256

"The Orange Book" 258

United States Pharmacopeia Drug Information® 258

United States Pharmacopeia 258

Martindale: The Extra Pharmacopoeia 258

AHFS-Drug Information Essentials 258

Risk management 261

Product Defects 263

Known Side Effects 263

Avoidable Side Effects 263

Unavoidable Side Effects 263

Medication or Device Errors 263

Unexpected Side Effects 264

Long-term Effects 264

Effects of Off-label Uses 264

Effects in Populations Not Studied 265

Remaining Uncertainties 265

Outcome and Pharmacoeconomics Research 265

Late-Phase Clinical Trials 267

References 272

12. Special Considerations in Research 275

12.1. Cardiovascular Drug Development 275

C. Michael White, Jessica Song, and Jeffrey Kluger

State of Cardiovascular Research 275

New Modalities 278

Cardiovascular Drug Development 279

Standard of Care 281

Clinical Trial Types 281

Acute and Chronic Therapy Trials 284

Special Populations Studies 286

Conclusions 290

References 290

12.2. Infectious Diseases 294

Ralph H. Raasch

"Bad Bugs, NO Drugs"—The Diminishing Antibiotic Pipeline 294

Problem of Antimicrobial Resistance 297

Rational Antibacterial Drug Development 300

Proposed Approaches to Address "Bad Bugs, NO Drugs" 306

References 307

12.3. Oncology 308

Suzanne F. Jones and Howard A. Burris III

Background Issues 309

Phase 1 Clinical Trials 310

Phase 2 Clinical Trials 313

Other Design Issues in Oncology 316

Era of Targeted Therapy 317

References 319

12.4. Pediatrics 321

Philip D. Walson

The Case for Pediatric Research with Drugs 322

American Academy of Pediatrics and Research 325

Legislative and Government Initiatives in Pediatric Research 327

The Science in Pediatric and Clinical Studies 333

References 337

12.5. Psychiatry 338

Michael W. Jam, John J. Brennan, and Roland Garritsen VanderHoop

Introduction 338

Patient Populations in Psychiatry 339

Acute versus Chronic Trials—Design and Conduct Issues 340

Pharmacology 344

Research Challenges 346

Dos 347

Don'ts 347

Summary 348

References 349

Appendix 1 351

Appendix 2 366

Index 374

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