Biologics, Biosimilars, and Biobetters
Wiley-Blackwell (Verlag)
978-1-119-56465-2 (ISBN)
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.
- 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
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.
Chapter 1: Innovator Biologics, Biosimilars and Biobetters: Terminology, Nomenclature and Definitions
Chapter 2: Approved Biologic Medicines and Biosimilars in Major Regulatory Jurisdictions
Chapter 3: Status of Biologic Drugs in Modern Therapeutics-Targeted Therapies vs Small Molecule Drugs
Chapter 4: Major Classes of Biotherapeutics
Chapter 5: Drug Targets for Biologics
Chapter 6: Pivotal Biology, Chemistry, Biochemistry and Biophysical Concepts of Biologics and Biosimilars
Chapter 7: Biosimilarity and Interchangeability of Biologic Drugs- General Principles, Biophysical Tests and Clinical Requirements to Demonstrate Biosimilarity
Chapter 8: Pharmacokinetics of Biologics
Chapter 9: Pharmacogenomics of Biologics
Chapter 10: International Regulatory Processes and Policies for Innovator Biologics, Biosimilars and Biobetters
Chapter 11: Pharmacovigilance of Innovator Biologics and Biosimilars
Chapter 12: Pharmacoeconomics of Biologic Medicines and Biosimilars (Gregory Reardon, Keck Graduate Institute, USA)
Chapter 13: New Emerging Biotherapies: Cutting-Edge Research to Experimental Therapies
Chapter 14: Optimising Use of Biologic Medicines Using a Quality Use of Medicines Approach
Chapter 15: Knowledge Areas and Competency Standards on Biologic Medicines for Pharmacists and Pharmacy Students
Chapter 16: A Checklist for Pharmacists on Biologics and Biosimilars - Tips to Enhance Patient-Centred Discussions
| Erscheinungsdatum | 09.03.2021 |
|---|---|
| Verlagsort | Hoboken |
| Sprache | englisch |
| Gewicht | 666 g |
| Einbandart | kartoniert |
| Themenwelt | Medizin / Pharmazie ► Pflege |
| Medizin / Pharmazie ► Pharmazie | |
| Naturwissenschaften ► Biologie | |
| Naturwissenschaften ► Chemie | |
| ISBN-10 | 1-119-56465-4 / 1119564654 |
| ISBN-13 | 978-1-119-56465-2 / 9781119564652 |
| Zustand | Neuware |
| Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
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