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Global New Drug Development: An Introduction (Postgraduate Pharmacy Series)

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en Limba Engleză Carte Hardback – 19 Sep 2014

Din seria Postgraduate Pharmacy Series

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Specificații

ISBN-13: 9781118414880
ISBN-10: 1118414888
Pagini: 424
Dimensiuni: 179 x 252 x 28 mm
Greutate: 0.91 kg
Editura: Wiley
Seria Postgraduate Pharmacy Series

Locul publicării: Chichester, United Kingdom

Public țintă

Primary Market:  :   MSc and equivalent postgraduate courses in  pharmaceutical sciences,  pharmacy and industrial pharmaceutical sciences.   There are now 18 universities offering Pharmaceutical Science with student number between 20 and 100 per year along with 26 pharmacy schools in the UK alone. 
Typical Course Names Level Typical Student Numbers Length of Course
Pharmacy undergraduate 1000/country One semester
Pharmaceutical Technology undergraduate 1000/country One semester
Pharmacy–PhD Post graduate 50/country Three years
Pharmacy–Master Post graduate 20/country Six months
   
   
Secondary Market:   Industry professionals  and drug product development scientists trainees, postgraduate researchers (possibly from wider disciplines such as Pharmaceutical Medicine).  Also Regulatory Bodies, Pharma, and R&D Companies and agency staff FDA, GPhC (GMC in the UK)
 

Cuprins

Series Foreword ix

Preface xi

Acknowledgement xiii

Abbreviations xv

Introduction xxi

1 Drug Life Cycle 1

1.1 Introduction 1

1.2 Drivers of the search for a new drug 2

1.3 Structure of a drug life cycle 5

1.4 Costs and risks of drug research and development 6

1.5 Risk of drug R&D 7

1.6 Value for patient and society 9

1.7 The end of a drug s life 9

1.8 Management 10

References 10

2 Drug Discovery and Design 13

2.1 Introduction 13

2.2 Approaches in drug discovery 14

2.3 The drug discovery process 17

References 21

3 Drug Development: General Aspects 23

3.1 Introduction 23

3.2 The objective of drug development 23

3.3 Drug development organisations and teams 24

3.4 Drug development streams 27

3.5 Phases in drug development 36

3.6 Regulatory environment 44

3.7 Quality management 58

3.8 Project risk management 75

3.9 Ethical considerations 79

References 88

4 Methods and Techniques Used in Drug Development 91

4.1 Introduction 91

4.2 Chemical and pharmaceutical development 91

4.3 Non–clinical development 106

4.4 Clinical development 139

References 166

5 The Early Development of a New Drug 169

5.1 Introduction 169

5.2 Preclinical phase 170

5.3 Clinical phase 200

References 251

6 The Late Development of a New Drug 253

6.1 Introduction 253

6.2 Pre–approval development 254

6.3 Marketing authorisation 316

6.4 Post–approval development 328

References 347

7 Special Drug Developments 351

7.1 Introduction 351

7.2 Development of orphan drugs 351

7.3 Paediatric drug development 354

7.4 Geriatric drug development 356

7.5 Development of fixed–dose drug combinations 358

7.6 Other special drug developments 360

References 360

8 Drug Commercialisation 361

8.1 Introduction 361

8.2 Market access 363

8.3 Pharmaceutical marketing 370

8.4 Independent drug information 382

8.5 Rational use of medicines 383

References 384

Epilogue 387

Index 391