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El. knyga: Pharmaceutical Medicine [Oxford Medicine Online E-books]

Edited by (Medical Director, Sanofi Pasteur MSD), Edited by (Medical Assessor, Medicines and Healthcare Products Regulatory Agency, UK), Edited by (Director of Clinical Research, GlaxoSmithKline, and Honorary Clinical Fellow, Addenbrooke's Hospital, Cambridge)
  • Formatas: 480 pages, 30 black and white images
  • Serija: Oxford Specialist Handbooks
  • Išleidimo metai: 23-May-2013
  • Leidėjas: Oxford University Press
  • ISBN-13: 9780199609147
Kitos knygos pagal šią temą:
  • Oxford Medicine Online E-books
  • Kaina nežinoma
Pharmaceutical MedicineDidesnis paveikslėlis
  • Formatas: 480 pages, 30 black and white images
  • Serija: Oxford Specialist Handbooks
  • Išleidimo metai: 23-May-2013
  • Leidėjas: Oxford University Press
  • ISBN-13: 9780199609147
Kitos knygos pagal šią temą:
Wiley OnlineMore info about Oxford Medicine Online e-books
Partnerių interneto svetainė: http://oxfordmedicine.com/view/10.1093/med/9780199609147.001.0001/med-9780199609147
Pharmaceutical Medicine provides an accessible, user-friendly and up-to-date handbook for those involved in clinical trials or marketing of new medicines in the pharmaceutical industry.

The breadth of the pharmaceutical medicine curriculum can be daunting, but this book is designed to navigate a path through the chaos. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts in an accessible and user-friendly format.

With 136 chapters spread across 8 sections, the text offers a thorough grounding in all aspects of the field, from regulatory control to trial-building and data management. This makes it a useful revision aid for exams as well as giving the reader a taster of areas of pharmaceutical medicine adjacent to their current role. For healthcare professionals already working in the field, the book offers a guiding hand in difficult situations as well as supplying access to the latest recommendations and guidelines. Comparing regulatory bodies and guidelines from around the world, it provides a truly global perspective that allows readers to confidently apply knowledge internationally.

Produced in the style of the accessible Oxford Handbook series with plenty of space for notes, it details the facts in a concise and readable format, without the reader having to dive through page upon page of dense text. Written by authors with over 20 years of experience in the industry, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.
Preface xi
Contributors xii
Abbreviations xiii
Section 1 Discovery of new medicines 1(16)
1.1 Intellectual property in discovery
2(3)
1.2 Targeted drug discovery: receptor-based approaches
5(3)
1.3 In vitro and in vivo testing of new compounds
8(3)
1.4 Lead optimization
11(3)
1.5 Natural products and herbal medicines
14(3)
Section 2 Medicines regulation 17(96)
2.1 General principles of medicines regulation
19(3)
2.2 Medicines regulation in the UK
22(3)
2.3 Medicines regulation in the EU
25(6)
2.4 The European Medicines Agency and Heads of Medicines Agencies
31(3)
2.5 The European Directorate for the Quality of Medicines and HealthCare, European Pharmacopoeia, and British Pharmacopoeia
34(3)
2.6 The Food and Drug Administration
37(3)
2.7 Health Canada
40(2)
2.8 Medsafe and the Therapeutic Goods Administration
42(3)
2.9 Medicines regulation in Japan
45(4)
2.10 Medicines regulation in China
49(3)
2.11 Medical device regulation
52(3)
2.12 Clinical trials regulation
55(3)
2.13 Good clinical practice
58(3)
2.14 Good laboratory practice and good clinical laboratory practice
61(3)
2.15 Good manufacturing practice
64(3)
2.16 The Ethics Committee (EU)
67(4)
2.17 The Institutional Review Board (US)
71(3)
2.18 Marketing authorization applications and updating and maintaining licences
74(3)
2.19 The International Conference on Harmonisation
77(3)
2.20 Common technical document
80(4)
2.21 Medicinal product information in the European Union
84(3)
2.22 Summary of product characteristics
87(3)
2.23 Orphan drugs
90(3)
2.24 Paediatric investigational plans
93(2)
2.25 Regulatory requirements for pharmacovigilance
95(3)
2.26 Overview of reporting of adverse drug reactions
98(3)
2.27 Non-prescription drugs
101(3)
2.28 Provision of unlicensed medicines
104(3)
2.29 Reclassification of medicines
107(4)
2.30 Parallel imports
111(2)
Section 3 Clinical pharmacology 113(86)
3.1 Absorption, distribution, metabolism, and excretion
115(4)
3.2 Volume of distribution, clearance, half-life
119(4)
3.3 Pre-clinical aspects of pharmacokinetics
123(3)
3.4 Non-clinical data
126(3)
3.5 Clinical aspects of pharmacokinetics
129(3)
3.6 Dose-response relationship
132(4)
3.7 Proof of concept studies
136(2)
3.8 Reproductive toxicity studies
138(4)
3.9 Immunotoxicity testing
142(4)
3.10 Carcinogenicity
146(3)
3.11 Genotoxicity testing
149(4)
3.12 Local tolerance
153(3)
3.13 Acute toxicity
156(2)
3.14 Studies: objectives, design, conduct, and analysis
158(4)
3.15 Populations for exploratory studies and planning of exploratory studies
162(3)
3.16 Pharmacodynamic endpoints
165(3)
3.17 Bioavailability and bioequivalence
168(3)
3.18 Evaluation of safety and tolerability
171(3)
3.19 Hypersensitivity reactions
174(3)
3.20 Drug-drug interactions
177(4)
3.21 Ethics in research: basic principles, Declaration of Helsinki, and Council for International Organizations of Medical Sciences
181(4)
3.22 Disease models
185(3)
3.23 Biomarkers
188(3)
3.24 Pharmacogenetics
191(2)
3.25 Population pharmacokinetics
193(2)
3.26 Small molecules and biologicals: safety and pharmacology requirements
195(4)
Section 4 Clinical development 199(52)
4.1 Requirements for licensing a new medicinal product
200(3)
4.2 Regulatory guidance
203(3)
4.3 General principles of clinical trial protocols
206(3)
4.4 Clinical study design
209(4)
4.5 Adaptive trial designs
213(2)
4.6 Informed consent
215(3)
4.7 Data protection
218(3)
4.8 Indemnity and compensation
221(3)
4.9 Investigator's brochure
224(3)
4.10 Organization of project teams/project planning
227(3)
4.11 Contractual arrangements with research sites and contract research organizations
230(3)
4.12 Case report form
233(3)
4.13 Budgeting and cost control
236(3)
4.14 Expanded access programmes
239(3)
4.15 Study master file preparation
242(5)
4.16 Target product profile
247(4)
Section 5 Statistics and data management 251(54)
5.1 Determining the sample size in a clinical trial
252(3)
5.2 Sensitivity and specificity
255(3)
5.3 Significance testing
258(3)
5.4 Type 1 and Type II error
261(3)
5.5 Confidence intervals
264(4)
5.6 Minimizing bias
268(3)
5.7 Paired and unpaired t-tests
271(3)
5.8 Parametric and non-parametric tests
274(3)
5.9 Patient reported outcomes
277(3)
5.10 Health-related quality of life
280(3)
5.11 Clinical interpretation of trial results
283(6)
5.12 Clinical study report
289(3)
5.13 Issues with making trial results available
292(3)
5.14 Interim analysis
295(3)
5.15 Data management
298(3)
5.16 Within trial data management
301(4)
Section 6 Drug safety and pharmacovigilance 305(44)
6.1 Pharmacovigilance
306(3)
6.2 Key pharmacovigilance regulations in the EU
309(3)
6.3 Good pharmacovigilance practices
312(3)
6.4 Periodic safety update reports
315(3)
6.5 Benefit-risk assessment
318(4)
6.6 Pharmacoepidemiological safety data
322(3)
6.7 Product suspension and withdrawal and defective medicines
325(3)
6.8 Safety signal
328(3)
6.9 Spontaneous reporting
331(3)
6.10 Post-authorization safety studies
334(3)
6.11 Dear Healthcare Professional communication
337(2)
6.12 Issues and crisis management
339(3)
6.13 Adverse events in clinical trials
342(4)
6.14 Risk management
346(3)
Section 7 Healthcare marketplace 349(68)
7.1 Marketing medicines: the drug lifecycle
351(4)
7.2 The Foreign Corrupt Practices Act and UK Bribery Act
355(4)
7.3 Product lifecycle management
359(3)
7.4 Ethical marketing of medicines
362(3)
7.5 World Health Organization ethical criteria for medicinal drug promotion
365(3)
7.6 Co-marketing and co-promotion
368(2)
7.7 In-licensing
370(3)
7.8 The Association of British Pharmaceutical Industries
373(3)
7.9 The Association of British Pharmaceutical Industries Code of Practice
376(3)
7.10 Pharmaceutical Research and Manufacturers of America
379(3)
7.11 The International Federation of Pharmaceutical Manufacturers & Associations Code of Practice
382(2)
7.12 The European Federation of Pharmaceutical Industries and Associations
384(3)
7.13 Medicines Australia
387(3)
7.14 National Institute for Health and Clinical Excellence
390(3)
7.15 The Scottish Intercollegiate Guidelines Network
393(3)
7.16 The Institute for Quality and Efficiency in Health Care
396(3)
7.17 Health economics
399(3)
7.18 Quality-adjusted life years
402(3)
7.19 Pharmacoepidemiology
405(3)
7.20 Branded generics
408(3)
7.21 Intellectual property
411(3)
7.22 Product liability and compensation
414(3)
Section 8 Therapeutics 417(24)
8.1 Medicines for children
418(3)
8.2 Medicines in pregnancy
421(4)
8.3 Medicines in the elderly
425(4)
8.4 Medicines for patients with hepatic impairment
429(4)
8.5 Medicines for patients with renal impairment
433(3)
8.6 Principles of benefit-risk
436(3)
8.7 Therapeutic drug monitoring
439(2)
Index 441
Dr. Adrian Kilcoyne graduated from Trinity College Dublin in 1995. Following time as a Registrar in Reproductive Medicine in London, he spent some time as a Specialist Registrar in Public Health Medicine in Oxford followed by some years as a GP. He completed a Masters in Public Health at the London School of Hygiene and Tropical Medicine and a Masters in Business Administration at Warwick Business School. He joined the pharmaceutical industry in 2006 to become a Senior Clinical Research Physician in Diabetes at Eli Lilly. He has since held Medical Director positions at Baxter Healthcare and Roche and is now Medical Director at Sanofi Pasteur MSD, a dedicated vaccine company. Adrian has completed the Diploma in Pharmaceutical Medicine and is a Member of the Faculty of Pharmaceutical Medicine and has completed Higher medical Training in Pharmaceutical medicine.





Dr. Daniel O'Connor is a Leicester medical graduate with a background in cancer research, histopathology and oncology. He joined the Medicines and Healthcare products Regulatory Agency (MHRA) as a Medical Assessor in 2006 from a clinical lecturer post at UCL/UCH/Ludwig Institute for Cancer Research. He works in the licensing division of the MHRA, mainly reviewing oncology products and is also the UK representative on the Committee for Orphan Medicinal Products (COMP). He completed specialist training in Pharmaceutical Medicine in 2012. He is a fellow of the Foulkes Foundation.

Dr. Phil Ambery qualified in medicine from the University of Bristol in 1994. He undertook registrar training in the South-West of England and in Sydney, before returning to the UK in 2000 to study diabetes and endocrinology before leaving the NHS to work for GlaxoSmithKline. Since then he has held various posts in the GSK commercial organisation and latterly as a clinical program leader in the metabolic and cardiovascular pathways group at Glaxo. He is also an honorary clinical fellow at Addenbrooke's Hospital Cambridge, and a GMC specialist partner. He has a number of publications in the field of diabetes and cardiovascular medicine, and on the MRCP examination.
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