Pharmaceutical Medicine

Paperback | June 5, 2013

EditorAdrian Kilcoyne, Phil Ambery, Daniel OConnor

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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-friendlyformat. 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 medicineadjacent 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 atruly 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, thiscomprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.

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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-friendlyformat. With 136 chapters spread across 8 section...

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 Medici...

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Format:PaperbackDimensions:477 pages, 7.09 × 3.94 × 0.07 inPublished:June 5, 2013Publisher:Oxford University PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0199609144

ISBN - 13:9780199609147

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Table of Contents

1. Therapeutic drug monitoring1.1 Intellectual Property in Discovery1.2 Targeted drug discovery: Receptor based approaches1.3 Invitro and invivo testing of new compounds1.4 Lead optimisation1.5 Natural Products and Herbal Medicines2. Medicines Regulation2.1 General Principles of Medicines Regulation2.2 Medicines Regulation in the UK2.3 Medicines Regulation in EU2.4 The European Medicines Agency and Heads of Medicine Agency2.4 European Directorate for the Quality of Medicines and Healthcare, the European Pharmacopoeia and the British Pharmacopoeia2.6 Food and Drug Administration2.7 Health Canada2.8 Medicines Regulation in Australia/NZ2.9 Medicines Regulation in Japan2.10 Medicines Regulation in China2.11 Medical Devices Regulation2.12 Clinical Trials Regulation2.13 Good Clinical Practice2.14 Good Laboratory Practice2.15 Good Manufacturing Practice2.16 Ethics Committee (European Union)2.17 Institutional Review Board (US)2.18 Marketing Authorisation Applications and updating and maintaining Licences2.19 International Conference on Harmonisation2.20 Common Technical Document2.21 Medicinal Product Information in the EU2.22 Summary of Product Characteristics2.23 Orphan Drugs2.24 Paediatric Investigational Plan2.25 Regulatory Requirements for Pharmacovigilance2.26 Overview of Reporting of Adverse Drug Reactions2.27 Non-prescription Drugs2.28 Provision of Unlicensed Medicines2.29 Reclassification Of Drugs2.30 Parallel imports3. Clinical Pharmacology3.1 ADME3.2 Volume of distribution, clearance, half-life3.3 Pre-clinical aspects of pharmacokinetics3.4 Non-clinical data3.5 Clinical aspects of pharmacokinetics3.6 Dose Response Relationship3.7 Proof of concept studies3.8 Reproductive Toxicity Studies3.9 Immunotoxicity studies3.10 Carcinogenicity3.11 Genotoxicity testing3.12 Local Tolerance3.13 Acute Toxicity3.14 Studies - objectives, design, conduct and analysis3.15 Populations for exploratory studies and planning of exploratory studies3.16 Pharmacodynamic endpoints3.17 Bioequivalence3.18 Evaluation of safety and tolerability3.19 Hypersensitivity reactions3.20 Drug-drug interactions3.21 Ethics in Research: Basic principles, Declaration of Helsinki and CIOMS3.22 Disease Models3.23 Biomarkers3.24 Pharmacogenetics3.25 Population Pharmacokinetics3.26 Small molecules and biologicals - safety / pharmacology requirements4. Clinical Development4.1 Requirements for licensing and new medicinal product4.2 Regulatory Guidance4.3 General principles of clinical trial protocols4.4 Clinical Study Design4.5 Adaptive trial designs4.6 Informed consent4.7 Data Protection4.8 Indemnity and compensation4.9 Investigators Brochure4.10 Organisation of project teams / project planning4.11 Contractual arrangements with research sites and Contract Research Organisations4.12 Case Report Form (CRF)4.13 Budgeting and cost control4.14 Expanded access programs4.15 Study master file preparation4.16 Target product profile5. Statistics and Data management5.1 Determining the sample size in a clinical trial5.2 Sensitivity and Specificity5.3 Significance testing5.4 Type I and Type II error5.5 Confidence intervals5.6 Minimising Bias5.7 Paired and Unpaired t-test5.8 Parametric and non parametric tests5.9 Patient Reported Outcomes5.10 Health Related Quality of life (HRQL)5.11 Clinical Interpretation of Trial Results5.12 Clinical Study Report5.13 Issues with making trial results available5.14 Interim Analysis5.15 Data Management5.16 Within-Trial Data Management6. Drug Safety and Pharmacovigilance6.1 Regulatory Requirements for Pharmacovigilance 6.16.2 Key pharmacovigilance regulations in the EU6.3 Volume 9A6.4 Periodic Safety Update Reports6.5 Benefit Risk Assessment6.6 Pharmacoepidemiological Safety Data6.7 Product Suspension and Withdrawal and Defective Medicines6.8 Safety Signal6.9 Spontaneous Reporting6.10 Post Authorisation Safety Studies (PASS)6.11 Dear Healthcare Professional Communication6.12 Issues and crisis management6.13 Adverse Events in Clinical Trials6.14 Risk Management7. Healthcare Marketplace7.1 Marketing Medicines: The drug Lifecycle7.2 FCPA and Bribery act7.3 Product life cycle management7.4 Ethical marketing of medicines7.5 World Health Organisation (WHO) Ethical Criteria for Medicinal Drug Promotional7.6 Co-marketing7.7 Inlicensing7.8 The Association of British Pharmaceutical Industries (ABPI)7.9 The ABPI Code of Practice7.10 PhRMA7.11 IFPMA code of practice7.12 The European Federation of Pharmaceutical Industries and Associations (EFPIA)7.13 Medicines Australia7.14 The National Institute for Health and Clinical Excellence (NICE)7.15 The Scottish Intercollegiate Guidelines Network (SIGN)7.16 IQWIG7.17 Health Economics7.18 Quality adjusted life years7.19 Pharmacoepidemiology7.20 Branded generics7.21 Intellectual property7.22 Product liability and compensation8. Therapeutics8.1 Medicines for Children8.2 Medicines in pregnancy8.3 Medicines in the elderly8.4 Medicines for patients with hepatic impairment8.5 Medicines for patients with renal impairment8.6 Principles of Risk Benefit8.7 Therapeutic drug monitoring