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E-grāmata: Drugs: From Discovery to Approval

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(Biopharmaceutical Manufacturing Technology Centre, Singapore)
  • Formāts: EPUB+DRM
  • Izdošanas datums: 28-Apr-2015
  • Izdevniecība: Wiley-Blackwell
  • Valoda: eng
  • ISBN-13: 9781118907191
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Drugs: From Discovery to ApprovalPalielināt
  • Formāts: EPUB+DRM
  • Izdošanas datums: 28-Apr-2015
  • Izdevniecība: Wiley-Blackwell
  • Valoda: eng
  • ISBN-13: 9781118907191
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The third edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products.

Concise and easy to read, Drugs: From Discovery to Approval, Third Edition quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. The third edition incorporates the latest developments and updates in the pharmaceutical community, provides more comprehensive coverage of topics, and includes more materials and case studies suited to college and university use. Biotechnology is a dynamic field with changes across R&D, clinical trials, manufacturing and regulatory processes, and the third edition of the text provides timely updates for those in this rapidly growing field.
Preface xv
1 Introduction 1(22)
1.1 Aim of this Book
1(1)
1.2 An Overview of the Drug Discovery to Approval Process
2(4)
1.3 The Pharmaceutical Industry
6(5)
1.4 Economics of Drug Discovery and Development
11(2)
1.5 Trends in Drug Discovery and Development
13(2)
1.6 Case Study #1.1
15(2)
1.7 Case Study #1.2
17(3)
1.8 Summary of Important Points
20(1)
1.9 Review Questions
20(1)
1.10 Brief Answers and Explanations
21(1)
1.11 Further Reading
22(1)
2 Drug Discovery: Targets And Receptors 23(38)
2.1 Drug Discovery Processes
23(1)
2.2 Medical Needs
24(2)
2.3 Target Identification
26(7)
2.4 Target Validation
33(3)
2.5 Drug Interactions with Targets or Receptors
36(4)
2.6 Enzymes
40(2)
2.7 Receptors and Signal Transduction
42(10)
2.8 Assay Development
52(1)
2.9 Case Study #2.1
52(1)
2.10 Case Study #2.2
53(4)
2.11 Summary of Important Points
57(1)
2.12 Review Questions
57(1)
2.13 Brief Answers and Explanations
58(1)
2.14 Further Reading
58(3)
3 Drug Discovery: Small Molecule Drugs 61(42)
3.1 Introduction
61(1)
3.2 Irrational Approach
62(5)
3.3 Rational Approach
67(18)
3.4 Antisense Approach
85(3)
3.5 RNA Interference Approach
88(3)
3.6 Chiral Drugs
91(1)
3.7 Closing Remarks
92(2)
3.8 Case Study #3.1
94(2)
3.9 Case Study #3.2
96(2)
3.10 Summary of Important Points
98(1)
3.11 Review Questions
99(1)
3.12 Brief Answers and Explanations
99(1)
3.13 Further Reading
100(3)
4 Drug Discovery: Large Molecule Drugs 103(48)
4.1 Introduction
103(2)
4.2 Vaccines
105(12)
4.3 Antibodies
117(11)
4.4 Cytokines
128(6)
4.5 Hormones
134(3)
4.6 Gene Therapy
137(2)
4.7 Stem Cells and Cell Therapy
139(2)
4.8 Case Study #4.1
141(3)
4.9 Case Study #4.2
144(2)
4.10 Summary of Important Points
146(1)
4.11 Review Questions
147(1)
4.12 Brief Answers and Explanations
148(1)
4.13 Further Reading
148(3)
5 Drug Development And Preclinical Studies 151(40)
5.1 Introduction
151(3)
5.2 Pharmacodynamics
154(4)
5.3 Pharmacokinetics
158(10)
5.4 Toxicology
168(4)
5.5 Animal Tests, In Vitro Assays, and In Silico Methods
172(3)
5.6 Formulations and Delivery Systems
175(8)
5.7 Nanotechnology
183(1)
5.8 Case Study #5.1
184(1)
5.9 Case Study #5.2
185(2)
5.10 Summary of Important Points
187(1)
5.11 Review Questions
188(1)
5.12 Brief Answers and Explanations
188(1)
5.13 Further Reading
189(2)
6 Clinical Trials 191(40)
6.1 Definition of Clinical Trial
191(1)
6.2 Ethical Considerations
192(3)
6.3 Clinical Trials
195(9)
6.4 Regulatory Requirements for Clinical Trials
204(11)
6.5 Clinical Data Management
215(3)
6.6 Role of Regulatory Authorities
218(1)
6.7 Gene Therapy Clinical Trial
218(2)
6.8 Adaptive Clinical Trial
220(1)
6.9 Meta-Analysis
221(1)
6.10 Case Study #6.1
222(4)
6.11 Case Study #6.2
226(1)
6.12 Summary of Important Points
227(1)
6.13 Review Questions
228(1)
6.14 Brief Answers and Explanations
228(1)
6.15 Further Reading
229(2)
7 Regulatory Authorities 231(22)
7.1 Role of Regulatory Authorities
231(2)
7.2 US Food and Drug Administration
233(3)
7.3 European Medicines Agency
236(2)
7.4 Japan's Pharmaceuticals and Medical Devices Agency (PMDA)
238(2)
7.5 China Food and Drug Administration
240(1)
7.6 India's Central Drugs Standard Control Organization
240(1)
7.7 Australia's Therapeutic Goods Administration
241(2)
7.8 Canada's Health Canada
243(1)
7.9 Other Regulatory Authorities
243(1)
7.10 Authorities other than Drug Regulatory Agencies
243(1)
7.11 International Conference on Harmonization
244(1)
7.12 World Health Organization
245(1)
7.13 Pharmaceutical Inspection Cooperation Scheme
246(1)
7.14 Case Study # 7.1
246(3)
7.15 Case Study # 7.2
249(1)
7.16 Summary of Important Points
250(1)
7.17 Review Questions
251(1)
7.18 Brief Answers and Explanations
251(1)
7.19 Further Reading
252(1)
8 Regulatory Applications 253(48)
8.1 Introduction
253(1)
8.2 United States
254(18)
8.3 European Union
272(8)
8.4 Japan
280(2)
8.5 China
282(5)
8.6 India
287(1)
8.7 Australia
287(1)
8.8 Canada
287(3)
8.9 Case Study #8.1
290(2)
8.10 Case Study #8.2
292(2)
8.11 Summary of Important Points
294(5)
8.12 Review Questions
299(1)
8.13 Brief Answers and Explanations
299(1)
8.14 Further Reading
300(1)
9 Good Manufacturing Practice: Regulatory Requirements 301(66)
9.1 Introduction
301(1)
9.2 United States
302(6)
9.3 Europe
308(1)
9.4 International Conference on Harmonization (ICH)
309(2)
9.5 Pharmaceutical Inspection Cooperation Scheme (PIC/S)
311(1)
9.6 Selected Core Elements of GMP
312(23)
9.7 Selected GMP Systems
335(15)
9.8 New cGMP Initiatives
350(2)
9.9 Case Study #9.1
352(6)
9.10 Case Study #9.2
358(4)
9.11 Summary of Important Points
362(1)
9.12 Review Questions
363(1)
9.13 Brief Answers and Explanations
363(1)
9.14 Further Reading
364(3)
10 Good Manufacturing Practice: Drug Manufacturing 367(44)
10.1 Introduction
367(4)
10.2 GMP Manufacturing
371(1)
10.3 GMP Inspection
372(7)
10.4 Manufacture of Small Molecule APIs (Chemical Synthesis Methods)
379(6)
10.5 Manufacture of Large Molecule APIs (Recombinant DNA Methods)
385(9)
10.6 Finished Dosage Forms
394(4)
10.7 Product Quality Review
398(1)
10.8 Manufacturing Variations
399(1)
10.9 Case Study #10.1
400(4)
10.10 Case Study #10.2
404(3)
10.11 Summary of Important Points
407(1)
10.12 Review Questions
408(1)
10.13 Brief Answers and Explanations
408(1)
10.14 Further Reading
408(3)
11 Future Perspectives 411(40)
11.1 Past Advances and Future Challenges
411(1)
11.2 Small Molecule Pharmaceutical Drugs
412(2)
11.3 Large Molecule Biopharmaceutical Drugs
414(1)
11.4 Traditional Medicine
414(5)
11.5 Personalized Medicine
419(1)
11.6 Gene Therapy
420(1)
11.7 Cloning and Stem Cells
420(3)
11.8 Old Age Diseases and Aging
423(1)
11.9 Lifestyle Drugs
423(5)
11.10 Performance-Enhancing Drugs
428(1)
11.11 Chemical and Biological Terrorism
428(4)
11.12 Transgenic Animals and Plants
432(1)
11.13 Antibiotics Drug Resistance
433(2)
11.14 Regulatory Issues
435(2)
11.15 Intellectual Property Rights and Marketing Exclusivities
437(3)
11.16 Bioethics
440(2)
11.17 Concluding Remarks
442(3)
11.18 Case Study #11.1
445(2)
11.19 Case Study #11.2
447(2)
11.20 Further Reading
449(2)
Appendix 1 History Of Drug Discovery And Development 451(6)
A1.1 Early History of Medicine
451(2)
A1.2 Drug Discovery and Development in the Middle Ages
453(1)
A1.3 Foundation of Current Drug Discovery and Development
454(1)
A1.4 Beginnings of Modern Pharmaceutical Industry
454(1)
A1.5 Evolution of Drug Products
455(1)
A1.6 Further Reading
456(1)
Appendix 2 Cells, Nucleic Acids, Genes, And Proteins 457(12)
A2.1 Cells
457(3)
A2.2 Nucleic Acids
460(2)
A2.3 Genes and Proteins
462(6)
A2.4 Further Reading
468(1)
Appendix 3 Selected Drugs And Their Mechanisms Of Action 469(12)
Appendix 4 A DHFR Plasmid Vector 481(2)
Appendix 5 Vaccine Production Methods 483(2)
Appendix 6 Vaccines Approved By FDA 485(4)
Appendix 7 Pharmacology/toxicology Review Format 489(6)
Appendix 8 Examples Of General Biomarkers 495(4)
Appendix 9 Toxicity Grading 499(6)
Appendix 10 Health Systems In Selected Countries 505(4)
Acronyms 509(6)
Glossary 515(4)
Index 519
Rick Ng, PhD, MBA, has worked for more than 25 years in senior management positions in the private sector pharmaceutical industry. He is currently providing consulting services to the pharmaceutical industry and training for graduates, postgraduates, and pharmaceutical professionals at the National University of Singapore and the University of New South Wales, Australia.
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