i -1 f, THOMAS rvl. JACOBSFN, PharmD y MS, RPh AtsodJatf Direct!; Medfcaljptef Incorporated

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1 It; MM MODERN Ul NDUSTRY 77 / <-/-; /- i -1 f, THOMAS rvl. JACOBSFN, PharmD y MS, RPh AtsodJatf Direct!; Medfcaljptef Incorporated Director;, ALBERT I. WERTHEIMER, PhD, MBA Center for) Pharmaceutical Health Services"Research.School of Pharmacy at Temple University ; JONES AND BARTLETT PUBLISHERS Sudbury, Massachusetts BOSTON TORONTO LONDON SINGAPORE

2 Brief CHAPTER 1 ED Drug Discovery: Mew Compounds 1 CHAPTER 2 O Pharmaceutical Formulation 35 CHAPTER 3 D Analytical Testing and Development 57 CHAPTER 4 D Manufacturing and Production 75 CHAPTERS D Ethics in Clinical Research 101_ CHAPTER 6 D Clinical Research 119 CHAPTER 7 Regulatory Affairs 131^ CHAPTER 8 E3 Medical Information 155 CHAPTER 9 EH Drug Safety and Pharmacovigilance 189 CHAPTER 10 Legal and Intellectual Property 203 CHAPTER 11 Sales and Marketing 215 CHAPTER 12 Finance 231

3 CHAPTER 13 D Pharmacoeconomics and Outcomes Research 247 CHAPTER 14 Q Public Affairs CHAPTER 15 D Generic Drugs CHAPTER 16 D Over-the-Counter Drugs CHAPTER 17 El Future Industry Trends vi Brief

4 Foreword Preface About the Editors Contributors xvii xix xxi xxiii CHAPTER 1 E3 Drug Discovery: New Compounds 1 Then and Now 1 Drug and Receptor 2 Modeling Molecules 2 Picturing Molecules 3 Picturing Interacting Molecules 4 Selection of Preferred Models 5 The Need for Crystals 6 The Double Helix and All That 6 Determining Nucleotide Sequences 7 From DNA to Protein 8 Converting DNA Sequences to Genomes 9 Structural Genomics 9 Genomes to Proteomes 11 Purifying Proteins and Growing Crystals 11 High-Throughput Systems for Growing Crystals 12 New and Novel Proteins 13 VII

5 Fitting Drug to Receptor in Silico and Culling Misfits 14 High-Throughput Chemistry: Combinatorial Synthesis 16 a A Combinatorial Example 17 High-Throughput Chemistry: Parallel Synthesis 18 Automated Cleanup 20 Product Characterization 20 Structural Genomics Leads to Structural Proteomics 21 Target Selection Through Structural Proteomics 21 High-Throughput Binding Studies 22 Assemble a Mouse 24 High-Throughput Screening: G-Protein-Coupled Receptors 25 n Structure of G-Protein-Coupled Receptors 25 n Monitoring Transfection 27 Validating Target Receptors 28 References 30 CHAPTER 2 D Pharmaceutical Formulation 35 Preclinical/Preformulation Testing 35 Dosage Form Design: Choosing a Dosage Form 37 a Formulation Basics 38 Problem Formulations 40 n Degradation Issues 40 Stability Testing 41 D Pilot Batches 42 Granulation 45 D Drying 46 n Milling 47 n Blending 47 a Scale-Up 47 a Process Validation 49 a General Concepts 50 a CGMP Regulations for Finished Pharmaceuticals (The Current Codified CGMP Regulations, CFR Parts 210 and 211) 51 a Preliminary Considerations 52 a Elements of Process Validation 52 a Documentation 54 Suggested Reading 55 CHAPTER 3 Analytical Testing and Development 57 Method Development 57 Column Selection 58 Mode of Detection 58 Mobile Phase Selection 58 viii

6 Method Optimization 59 Effect of Buffer 59 CoIumn-to-Column Equivalency 61 Effect of Temperature 61 Effect of Ion Pair Reagent 61 Definitions 67 Stability Testing 67 o Drug Substance 67 Drug Product 68 q Glossary of Terms for Analytical and Method Development 69 Dissolution Test for Solid Dosage Forms 72 References 74 CHAPTER 4 B Manufacturing and Production 75 Active Pharmaceutical Ingredient (Drug Substance) 75 Manufacturing Equipment 76 Storage and Distribution 76 General Controls 77 Validation 78 Master Production Instructions 80 Batch Production Records 80 Finished Dosage Forms (Drug Product) 81 Description of the Manufacturing Process and Process Controls 82 Control of Excipients 83 Control of Drug Product 86 Container Closure Systems 88 Stability 90 Individual Dosage Forms 91 n Solid Oral Dosage Forms 91 Parenterals 92 Ophthalmic Drug Products 95 Metered Dose and Dry Powder Drug Products 96 Topical Drug Products 97 Suggested Reading 98 ix

7 CHAPTERS D Ethics in Clinical Research Clinical Research Versus Clinical Practice 101 Ethics and Clinical Research 101 Ethical Foundations 102 a Nuremberg Code 102 a Declaration of Helsinki 104 D Belmont Report 106 Rules and Regulations 107 a Code of Federal Regulations 108 a European Union Clinical Trials Directive 108 D International Conference'on Harmonisation 109 Protection of Human Subjects 109 D institutional Review Boards and Independent Ethics Committees 110 n Informed Consent 111 Ethical Research Methodologies 115 N D Randomized Clinical Trials 116 a Placebo Controlled Trials 116 Summary 116 References 116 UM CHAPTER 6 G Clinical Research 119 What Is Clinical Research? 119 Historical Perspective on Clinical Research 119 Why Is Clinical Research Needed? 120 The Phases of Drug Development 120 Where Clinical Research Begins 122 Critical Concepts in Clinical Research 122 Approaches to the Design of Clinical Research Studies 123 Bias in Clinical Research 125 Challenges in Conducting Clinical Research 127 The Interpretation and Integration of Clinical Research Into Clinical Practice 127 What Does the Future Hold for Clinical Research and What Opportunities Exist for Allied Health Professionals? 129 Suggested Reading 129

8 CHAPTER 7 Regulatory Affairs 131 International Conference on Harmonisation 132 The Investigational New Drug Application 133 Meetings With the FDA 138 The New Drug Application 139 The Common Technical Document 145 Electronic Documents 146 Communication During the Review Period 146 Postapproval Communication 148 Labeling Initiatives 150 Conclusion 150 References 151 CHAPTER 8 D Medical Information 155 Role of the Pharmacist in the Pharmaceutical Industry 155 Drug Information as a Pharmacy Specialty 160 History of Drug Information 161 n Drug Information Venues 161 Medical Information and Communications Within the Pharmaceutical Industry 163 Functions of a Medical Information and Communications Department 165 a Responding to Inquiries for Drug Information 165 n Responding to Drug Information Requests from the Healthcare Professional 166 a Standard Written Responses 167 a Special Circumstances 169 a Anticipated Changes in Request Volume 170 n Responding to Drug Information Requests from the Consumer 170 Maximizing Resources to Create Efficiencies in the Provision of Medical Information 171 a Handling Adverse Events and Product Complaints 172 a Participating in Promotional Review 172 Participating in Sales Training Activities 173 a Launch Preparation 173 n Resource Allocation and Launch Plan Development 174 n Support of Other Departments 174 a Core Launch Materials 175 a Training 175 o Evaluation and Reassessment 176 a Scientific Meeting Support 176 a Other Services of the Medical Information and Communications Department 177 xi

9 Evaluation of Medical Information and Communications Department Services 177 n Using Surveys as a Quality Assurance Measure 178 The Pharmaceutical Industry as a Career 178 a Introduction to the Pharmaceutical Industry in the School of Pharmacy Curriculum 179 Educational Opportunities for the Student Interested in Industry as a Career 179 a Internships 179 Clerkships 180- D Residencies and Fellowships 181 a Additional Skills 183 a Career Development Opportunities 183 Evolution of Medical Information and Communications in the Pharmaceutical Industry 183 a Increased Volume and Sophistication of Inquiries 183 o Novel Technology 184 n Globalization 184 Other Factors 184 Summary 185 References 185 CHAPTER 9 Drug Safety and Pharmacovigilance 189 History of Drug Safety in the United States 190 Classifications of Adverse Drug Events 191 Adverse Drug Reactions: Classifications, Severity, Outcomes, and Probability 192 Overview of the Scope of the Drug Safety Problem 195 ADRs With New Drug Entities: Clinical Trial Sample Size and Postmarketing Surveillance 195 Current Problems With Drug Safety and the FDA 198 Proposals for Improvement in Drug Safety 199 Conclusion 200 References 200 CHAPTER 10 D Legal and Intellectual Property 203 The Patent System 203 a Conditions for Patentability 204 a Types of Patents 205 n The Patent Process 206 n Patent Term Extension and the Pharmaceutical Industry 208 xii

10 Trademarks 208 n Selecting a Drug Name 209 a Types of Trademarks 210 a The Trademark Process 211 References 213 CHAPTER 11 E3 Sales and Marketing 215 The Marketing Processes 215 Marketing Analysis v 216 a Secondary Data 216 n Primary Data 217 Marketing Planning 218 a Marketing Strategy and Marketing Objectives 219 Promotional Strategy and Promotional Objectives 219 n Labeling Needs and Clinical Development Needs 220 a Reimbursement and Pricing 220 Implementation of the Marketing Plan 221 n The Promotion Plan 221 n Sales Forces 223 Control of the Marketing Plan 226 Other Aspects 226 The Interview 229 Additional Resources 229 CHAPTER 12 Q Finance 231_ Finance and Accounting 231 a Corporate Finance 231 a Accounting 232 o Financial Planning 233 a Equity Financing 233 Introduction to Strategic Planning 234 o Approach to Strategic Planning 234 a Analyzing Strengths, Weaknesses, Opportunities, and Threats: SWOT Analysis 235 The Mission 236 D The Vision 236 n Key Results Areas 236 n Developing Business Strategies 236 a Why Strategic Plans Fail 236 Pricing 237 n Chargebacks 237 a Rebates 239 n Private Sector Pricing 241 Federal Drug Discount Programs* 242 Discount Pricing Opportunities for States 243 Sarbanes-Oxley Act of References 245 Additional Resources 245 xiii

11 CHAPTER 13 O Pharmacoeconomics and Outcomes Research 247 Definition 248 History of Outcomes Research 248 Other Types of Outcomes Besides Clinical Outcomes 249 a Economic Outcomes 250 a Humanistic Outcomes 250 Types of Pharmacoeconomic Evaluation 251 Cost-Effectiveness 251 a Cost Utility 251 a Cost Minimization 251 a Cost-Benefit 252 Different Types of Outcomes Research Study Designs 252 n Retrospective Study Design 252 o Prospective Study Design 253 Why Are Outcomes Research and Pharmacoeconomics Done by the Pharmaceutical Industry? 253 Not All Drugs Work for 100% of Patients 254 Piggyback Pharmacoeconomics on Clinical Trials 256 Other Issues 256 References 257 CHAPTER 14 B Public Affairs 259 Introduction 259 Inside the Department 260 Public Relations 261 Investor Relations 263 Government Relations 263 Media Relations 264 Intelligence Gathering 265 Purchasing Influence 265 Measuring Success 265 Threats to the Pharmaceutical Industry 266 Who Works in a Public Affairs Department? 266 The Value of a Public Affairs Department 266 xiv

12 CHAPTER 15 D Generic Drugs 269 The History 269 Generic Pharmaceutical Industry Growth 270 Understanding Generic Pharmaceuticals 271 a Abbreviated Drug Approval Process 273 o Major Requirements for FDA Approval: Generic Drug 274 Generics Are the Same 276 Future Opportunities with Biogenerics 277 The Future of the US Generic Industry 278 References 279 Suggested Reading 279 CHAPTER 16 E3 Over-the-Counter Drugs 2jM The Hypothetical 281 OTC Regulation 282 a OTC Classification and the Importance of Labeling 282 Routes to Market: Monographs or NDAs 284 Rx-to-OTC Switch 285 a The Hypothetical 285 n Background 286 Advertising 287 Retail Environment 290 a The Hypothetical 291 a Background 291 Selling to Retailers 292 Conclusion: The Hypothetical Ends 293 References 293 CHAPTER 17 m Future Industry Trends 295 The Future Fear 296 Individualized Medicine 297 Nanotechnology 299 Discussion and Conclusions 300 References 302 Index 305 xv

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