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A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective.
* Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about
* Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence
* Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists
List of contents
List of Contributors vii
Foreword ix
Preface xi
1 Innovator Biologics, Biosimilars, and Biobetters: Terminology, Nomenclature, and Definitions 1
2 Approved Biologic Medicines and Biosimilars in Major Regulatory Jurisdictions 17
3 Status of Biologic Drugs in Modern Therapeutics-Targeted Therapies vs. Small Molecule Drugs 31
4 Major Classes of Biotherapeutics 47
5 Drug Targets for Biologics 71
6 Pivotal Biology, Chemistry, Biochemistry, and Biophysical Concepts of Biologics and Biosimilars 89
7 Biosimilarity and Interchangeability of Biologic Drugs-General Principles, Biophysical Tests, and Clinical Requirements to Demonstrate Biosimilarity 109
8 Pharmacokinetics of Biologics 125
9 Pharmacogenomics of Biologics 147
10 International Regulatory Processes and Policies for Innovator Biologics, Biosimilars, and Biobetters 159
11 Pharmacovigilance of Innovator Biologics and Biosimilars 177
12 Pharmacoeconomics of Biologic Medicines and Biosimilars 195
13 New Emerging Biotherapies: Cutting-Edge Research to Experimental Therapies 213
14 Optimizing Use of Biologic Medicines Using a Quality Use of Medicines Approach 237
15 Knowledge Areas and Competency Standards on Biologic Medicines for Pharmacists and Pharmacy Students 253
16 A Checklist for Pharmacists on Biologics and Biosimilars: Tips to Enhance Patient-Centered Discussions 267
Index 295
About the author
IQBAL RAMZAN is Professor of Pharmaceutical Sciences at The University of Sydney's School of Pharmacy, having recently stepped down as Dean after 12 years (2006-2017). Professor Ramzan is a recognized expert in drug pharmacokinetics/pharmacodynamics, has published 150 refereed papers, and has provided high level advice to the Australian Government on drug registration. He is an international leader in Pharmacy education and is a Past-President of the Asian Association of Schools of Pharmacy and the Council of Pharmacy Schools ? Australia and New Zealand. Professor Ramzan is a pharmacist, holds a PhD from The University of Sydney, and has an academic career spanning over 40 years.
Summary
A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective.
* Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about
* Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence
* Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists
