6.4.3 TIFAC (Technology Information Forecasting and

Assessment Council) 95

6.4.4 BCIL (Biotech Consortium India Limited) 97

6.4.5 TBSE (Technology Bureau for Small Enterprises)/SIDBI

(Small Industries Development Bank of India) 98

6.5 TOT Related Documentation 99

6.5.1 Confidentiality Agreements 99

6.5.2 Licensing 100

6.5.3 MoU 102

6.5.4 Legal Issues 103

Long Answer Type Questions 104

Short Answer Type Questions 104

Objective Type Questions 104

Summary 107

UNIT 3: Regulatory Affairs and Regulatory Requirements for Drug Approval

7. Regulatory Affairs and its Role 114

7.1 Introduction 114

7.2 Historical Overview of Regulatory Affairs 115

7.3 Regulatory Authorities 116

7.4 Role of Regulatory Affairs Department 117

7.5 Responsibility of Regulatory Affairs Professionals 119

Long Answer Type Questions 120

Short Answer Type Questions 120

Objective Type Questions 120

8. Drug Development and Non-Clinical Studies 122

8.1 Drug Development Teams 122

8.2 Non-clinical Drug Development 124

8.3 Toxicology 126

8.4 Drug Metabolism 126

Long Answer Type Questions 128

Short Answer Type Questions 128

Objective Type Questions 128

xiv Industrial Pharmacy II

9. INDA and NDA 130

9.1 General Considerations of Investigational New Drug (IND)

Application 130

9.2 Investigator’s Brochure (IB) 131

9.3 New Drug Application (NDA) 132

9.4 Clinical Research/BE (Bioequivalence) Studies 134

9.5 Biostatistics in Pharmaceutical Product Development 136

9.6 Data Presentation for FDA Submissions 138

9.7 Management of Clinical Studies 139

Long Answer Type Questions 139

Short Answer Type Questions 140

Objective Type Questions 140

Summary 142

UNIT 4: Quality Management Systems

10. Quality and Related Concepts 150

10.1 Concept of Quality 150

10.2 Quality Control 155

10.3 Quality Assurance 156

10.4 Comparison Between Quality Control and Quality Assurance 156

Long Answer Type Questions 157

Short Answer Type Questions 157

Objective Type Questions 157

11. Total Quality Management and Other Quality Management

Systems 159

11.1 Total Quality Management (TQM) 159

11.1.1 Origin of TQM 159

11.1.2 Characteristics of TQM 159

11.1.3 Principles of TQM 160

11.1.4 Key Elements of TQM 160

11.1.5 Main Objective of TQM: Continuous Improvement 161

11.1.6 Importance of TQM in the Pharmaceutical Industry 163

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