Drugs: From Discovery to Approval

555 Pages·2015·3.51 MB·English

by  Rick Ng

DRUGS

DRUGS
From Discovery to Approval
Third Edition
RICK NG, PhD, MBA
Trainer
NationalUniversityofSingaporeAcademyofGxPExcellence(NUSAGE)
Singapore
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CONTENTS
PREFACE xv
1 INTRODUCTION 1
1.1 AimofthisBook / 1
1.2 AnOverviewoftheDrugDiscoverytoApprovalProcess / 2
1.3 ThePharmaceuticalIndustry / 6
1.4 EconomicsofDrugDiscoveryandDevelopment / 11
1.5 TrendsinDrugDiscoveryandDevelopment / 13
1.6 CaseStudy#1.1 / 15
1.7 CaseStudy#1.2 / 17
1.8 SummaryofImportantPoints / 20
1.9 ReviewQuestions / 20
1.10 BriefAnswersandExplanations / 21
1.11 FurtherReading / 22
2 DRUGDISCOVERY:TARGETSANDRECEPTORS 23
2.1 DrugDiscoveryProcesses / 23
2.2 MedicalNeeds / 24
2.3 TargetIdentification / 26
2.4 TargetValidation / 33
2.5 DrugInteractionswithTargetsorReceptors / 36
2.6 Enzymes / 40
vii
viii CONTENTS
2.7 ReceptorsandSignalTransduction / 42
2.8 AssayDevelopment / 52
2.9 CaseStudy#2.1 / 52
2.10 CaseStudy#2.2 / 53
2.11 SummaryofImportantPoints / 57
2.12 ReviewQuestions / 57
2.13 BriefAnswersandExplanations / 58
2.14 FurtherReading / 58
3 DRUGDISCOVERY:SMALLMOLECULEDRUGS 61
3.1 Introduction / 61
3.2 IrrationalApproach / 62
3.3 RationalApproach / 67
3.4 AntisenseApproach / 85
3.5 RNAInterferenceApproach / 88
3.6 ChiralDrugs / 91
3.7 ClosingRemarks / 92
3.8 CaseStudy#3.1 / 94
3.9 CaseStudy#3.2 / 96
3.10 SummaryofImportantPoints / 98
3.11 ReviewQuestions / 99
3.12 BriefAnswersandExplanations / 99
3.13 FurtherReading / 100
4 DRUGDISCOVERY:LARGEMOLECULEDRUGS 103
4.1 Introduction / 103
4.2 Vaccines / 105
4.3 Antibodies / 117
4.4 Cytokines / 128
4.5 Hormones / 134
4.6 GeneTherapy / 137
4.7 StemCellsandCellTherapy / 139
4.8 CaseStudy#4.1 / 141
4.9 CaseStudy#4.2 / 144
4.10 SummaryofImportantPoints / 146
4.11 ReviewQuestions / 147
4.12 BriefAnswersandExplanations / 148
4.13 FurtherReading / 148