John Wiley & Sons Biologics, Biosimilars, and Biobetters Cover This book explores the fundamental scientific, clinical, policy, and regulatory issues surrounding b.. Product #: 978-1-119-56465-2 Regular price: $129.91 $129.91 Auf Lager

Biologics, Biosimilars, and Biobetters

An Introduction for Pharmacists, Physicians and Other Health Practitioners

Ramzan, Iqbal (Herausgeber)

Cover

1. Auflage März 2021
320 Seiten, Softcover
Wiley & Sons Ltd

ISBN: 978-1-119-56465-2
John Wiley & Sons

Kurzbeschreibung

This book explores the fundamental scientific, clinical, policy, and regulatory issues surrounding biologics, biosimilars, and biobetters from a practical and clinical perspective. Pharmacists require an understanding of the battery of biophysical tests needed to establish equivalence, efficacy, safety, and clinical risks of switching not only from an originator biologic to a biosimilar or a biobetter but from any biologic compound to another. There are also practical considerations such as dosing schedules and method(s) of administration that should be considered alongside efficacy, safety and cost when deciding on specific agents. The book provides regulators pragmatic approaches to deal with these drugs in the context of rapidly evolving scientific and clinical evidence. It concludes with a checklist for pharmacists to facilitate conversations with physicians and advice to patients to ensure quality use of medicine (QUM) for biologics, biosimilars, and biobetters.

Jetzt kaufen

Preis: 139,00 €

Preis inkl. MwSt, zzgl. Versand

Weitere Versionen

epubmobipdf

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 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
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.

I. Ramzan, The University of Sydney's School of Pharmacy