Pharmaceutical medicine / edited by Adrian Kilcoyne, Phil Ambery, Daniel O'Connor.

Format:

Book

Contributor:

Kilcoyne, Adrian.

Ambery, Phil.

O'Connor, Daniel J. (Medical assessor)

Series:

Oxford Specialist Handbooks

Oxford specialist handbooks

Language:

English

Subjects (All):

Clinical pharmacology.

Drug development.

Drugs--Research.

Drugs.

Physical Description:

1 online resource (473 p.)

Place of Publication:

Oxford : Oxford University Press, 2013.

Language Note:

English

Summary:

The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas o

Contents:

Cover; Contents; Preface; Contributors; Abbreviations; Section 1: Discovery of new medicines; 1.1 Intellectual property in discovery; 1.2 Targeted drug discovery: receptor-based approaches; 1.3 In vitro and in vivo testing of new compounds; 1.4 Lead optimization; 1.5 Natural products and herbal medicines; Section 2: Medicines regulation; 2.1 General principles of medicines regulation; 2.2 Medicines regulation in the UK; 2.3 Medicines regulation in the EU; 2.4 The European Medicines Agency and Heads of Medicines Agencies

2.5 The European Directorate for the Quality of Medicines and HealthCare, European Pharmacopoeia, and British Pharmacopoeia2.6 The Food and Drug Administration; 2.7 Health Canada; 2.8 Medsafe and the Therapeutic Goods Administration; 2.9 Medicines regulation in Japan; 2.10 Medicines regulation in China; 2.11 Medical device regulation; 2.12 Clinical trials regulation; 2.13 Good clinical practice; 2.14 Good laboratory practice and good clinical laboratory practice; 2.15 Good manufacturing practice; 2.16 The Ethics Committee (EU); 2.17 The Institutional Review Board (US)

2.18 Marketing authorization applications and updating and maintaining licences2.19 The International Conference on Harmonisation; 2.20 Common technical document; 2.21 Medicinal product information in the European Union; 2.22 Summary of product characteristics; 2.23 Orphan drugs; 2.24 Paediatric investigational plans; 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 medicines; 2.30 Parallel imports; Section 3: Clinical pharmacology

3.1 Absorption, distribution, metabolism, and excretion3.2 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 testing; 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 Bioavailability and bioequivalence3.18 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 Council for International Organizations of Medical Sciences; 3.22 Disease models; 3.23 Biomarkers; 3.24 Pharmacogenetics; 3.25 Population pharmacokinetics; 3.26 Small molecules and biologicals: safety and pharmacology requirements; Section 4: Clinical development; 4.1 Requirements for licensing a new medicinal product; 4.2 Regulatory guidance

4.3 General principles of clinical trial protocols

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

Description based on publisher supplied metadata and other sources.

ISBN:

0-19-101589-X

0-19-174277-5

0-19-151039-4

OCLC:

854854023