Biologics, Biosimilars, and Biobetters: An Introduction for Pharmacists, Physicians and Other Health Practitioners

ISBN-13: 9781119564652 / Angielski / Miękka / 2021 / 320 str.

Iqbal Ramzan

Spis treści

List of Contributors viiForeword ixPreface xi1 Innovator Biologics, Biosimilars, and Biobetters: Terminology, Nomenclature, and Definitions 12 Approved Biologic Medicines and Biosimilars in Major Regulatory Jurisdictions 173 Status of Biologic Drugs in Modern Therapeutics-Targeted Therapies vs. Small Molecule Drugs 314 Major Classes of Biotherapeutics 475 Drug Targets for Biologics 716 Pivotal Biology, Chemistry, Biochemistry, and Biophysical Concepts of Biologics and Biosimilars 897 Biosimilarity and Interchangeability of Biologic Drugs-General Principles, Biophysical Tests, and Clinical Requirements to Demonstrate Biosimilarity 1098 Pharmacokinetics of Biologics 1259 Pharmacogenomics of Biologics 14710 International Regulatory Processes and Policies for Innovator Biologics, Biosimilars, and Biobetters 15911 Pharmacovigilance of Innovator Biologics and Biosimilars 17712 Pharmacoeconomics of Biologic Medicines and Biosimilars 19513 New Emerging Biotherapies: Cutting-Edge Research to Experimental Therapies 21314 Optimizing Use of Biologic Medicines Using a Quality Use of Medicines Approach 23715 Knowledge Areas and Competency Standards on Biologic Medicines for Pharmacists and Pharmacy Students 25316 A Checklist for Pharmacists on Biologics and Biosimilars: Tips to Enhance Patient-Centered Discussions 267Index 295

O autorze

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.