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Produktbild: Pharmaceutical Medicine

Pharmaceutical Medicine Oxford Specialist Handbooks

Aus der Reihe Oxford Specialist Handbooks

Fr. 103.00

inkl. gesetzl. MwSt., Versandkostenfrei

Beschreibung

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

12.07.2013

Herausgeber

Adrian Kilcoyne + weitere

Verlag

Oxford University Press

Seitenzahl

480

Maße (L/B/H)

17.8/9.9/2 cm

Gewicht

228 g

Sprache

Englisch

ISBN

978-0-19-960914-7

Beschreibung

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

12.07.2013

Herausgeber

Verlag

Oxford University Press

Seitenzahl

480

Maße (L/B/H)

17.8/9.9/2 cm

Gewicht

228 g

Sprache

Englisch

ISBN

978-0-19-960914-7

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  • Produktbild: Pharmaceutical Medicine
  • 1. Therapeutic drug monitoring; 1.1 Intellectual Property in Discovery; 1.2 Targeted drug discovery: Receptor based approaches; 1.3 Invitro and invivo testing of new compounds; 1.4 Lead optimisation; 1.5 Natural Products and Herbal Medicines; 2. Medicines Regulation; 2.1 General Principles of Medicines Regulation; 2.2 Medicines Regulation in the UK; 2.3 Medicines Regulation in EU; 2.4 The European Medicines Agency and Heads of Medicine Agency; 2.5 European Directorate for the Quality of Medicines and Healthcare, the European Pharmacopoeia and the British Pharmacopoeia; 2.6 Food and Drug Administration; 2.7 Health Canada; 2.8 Medicines Regulation in Australia/NZ; 2.9 Medicines Regulation in Japan; 2.10 Medicines Regulation in China; 2.11 Medical Devices Regulation; 2.12 Clinical Trials Regulation; 2.13 Good Clinical Practice; 2.14 Good Laboratory Practice; 2.15 Good Manufacturing Practice; 2.16 Ethics Committee (European Union); 2.17 Institutional Review Board (US); 2.18 Marketing Authorisation Applications and updating and maintaining Licences; 2.19 International Conference on Harmonisation; 2.20 Common Technical Document; 2.21 Medicinal Product Information in the EU; 2.22 Summary of Product Characteristics; 2.23 Orphan Drugs; 2.24 Paediatric Investigational Plan; 2.25 Regulatory Requirements for Pharmacovigilance; 2.26 Overview of Reporting of Adverse Drug Reactions; 2.27 Non-prescription Drugs; 2.28 Provision of Unlicensed Medicines; 2.29 Reclassification Of Drugs; 2.30 Parallel imports; 3. Clinical Pharmacology; 3.1 ADME; 3.2 Volume of distribution, clearance, half-life; 3.3 Pre-clinical aspects of pharmacokinetics; 3.4 Non-clinical data; 3.5 Clinical aspects of pharmacokinetics; 3.6 Dose Response Relationship; 3.7 Proof of concept studies; 3.8 Reproductive Toxicity Studies; 3.9 Immunotoxicity studies; 3.10 Carcinogenicity; 3.11 Genotoxicity testing; 3.12 Local Tolerance; 3.13 Acute Toxicity; 3.14 Studies - objectives, design, conduct and analysis; 3.15 Populations for exploratory studies and planning of exploratory studies; 3.16 Pharmacodynamic endpoints; 3.17 Bioequivalence; 3.18 Evaluation of safety and tolerability; 3.19 Hypersensitivity reactions; 3.20 Drug-drug interactions; 3.21 Ethics in Research: Basic principles, Declaration of Helsinki and CIOMS; 3.22 Disease Models; 3.23 Biomarkers; 3.24 Pharmacogenetics; 3.25 Population Pharmacokinetics; 3.26 Small molecules and biologicals - safety / pharmacology requirements; 4. Clinical Development; 4.1 Requirements for licensing and new medicinal product; 4.2 Regulatory Guidance; 4.3 General principles of clinical trial protocols; 4.4 Clinical Study Design; 4.5 Adaptive trial designs; 4.6 Informed consent; 4.7 Data Protection; 4.8 Indemnity and compensation; 4.9 Investigators Brochure; 4.10 Organisation of project teams / project planning; 4.11 Contractual arrangements with research sites and Contract Research Organisations; 4.12 Case Report Form (CRF); 4.13 Budgeting and cost control; 4.14 Expanded access programs; 4.15 Study master file preparation; 4.16 Target product profile; 5. Statistics and Data management; 5.1 Determining the sample size in a clinical trial; 5.2 Sensitivity and Specificity; 5.3 Significance testing; 5.4 Type I and Type II error; 5.5 Confidence intervals; 5.6 Minimising Bias; 5.7 Paired and Unpaired t-test; 5.8 Parametric and non parametric tests; 5.9 Patient Reported Outcomes; 5.10 Health Related Quality of life (HRQL); 5.11 Clinical Interpretation of Trial Results; 5.12 Clinical Study Report; 5.13 Issues with making trial results available; 5.14 Interim Analysis; 5.15 Data Management; 5.16 Within-Trial Data Management; 6. Drug Safety and Pharmacovigilance; 6.1 Regulatory Requirements for Pharmacovigilance 6.1; 6.2 Key pharmacovigilance regulations in the EU; 6.3 Volume 9A; 6.4 Periodic Safety Update Reports; 6.5 Benefit Risk Assessment; 6.6 Pharmacoepidemiological Safety Data; 6.7 Product Suspension and Withdrawal & Defective Medicines; 6.8 Safety Signal; 6.9 Spontaneous Reporting; 6.10 Post Authorisation Safety Studies (PASS); 6.11 Dear Healthcare Professional Communication; 6.12 Issues and crisis management; 6.13 Adverse Events in Clinical Trials; 6.14 Risk Management; 7. Healthcare Marketplace; 7.1 Marketing Medicines: The drug Lifecycle; 7.2 FCPA and Bribery act; 7.3 Product life cycle management; 7.4 Ethical marketing of medicines; 7.5 World Health Organisation (WHO) Ethical Criteria for Medicinal Drug Promotional; 7.6 Co-marketing; 7.7 Inlicensing; 7.8 The Association of British Pharmaceutical Industries (ABPI); 7.9 The ABPI Code of Practice; 7.10 PhRMA; 7.11 IFPMA code of practice; 7.12 The European Federation of Pharmaceutical Industries and Associations (EFPIA); 7.13 Medicines Australia; 7.14 The National Institute for Health and Clinical Excellence (NICE); 7.15 The Scottish Intercollegiate Guidelines Network (SIGN); 7.16 IQWIG; 7.17 Health Economics; 7.18 Quality adjusted life years; 7.19 Pharmacoepidemiology; 7.20 Branded generics; 7.21 Intellectual property; 7.22 Product liability and compensation; 8. Therapeutics; 8.1 Medicines for Children; 8.2 Medicines in pregnancy; 8.3 Medicines in the elderly; 8.4 Medicines for patients with hepatic impairment; 8.5 Medicines for patients with renal impairment; 8.6 Principles of Risk Benefit; 8.7 Therapeutic drug monitoring