Biomarkers, diagnostics and precision medicine in the drug industry : critical challenges, limitations and roadmaps for the best practices / Abdel Halim

Front Cover; Biomarkers, Diagnostics, and Precision Medicine in the Drug Industry; Copyright Page; Dedication; Contents; Preface; 1 Pharmaceutical crisis; 1.1 Value of medicines; 1.1.1 Examples of major achievements; 1.1.2 Medications for the two leading causes of death; 1.1.3 Advancement in orphan drug development; 1.2 Drug development crisis; 1.2.1 Cost of medicines; 1.2.2 What factors determine a medication price?; 1.2.3 Spend on pharmaceutical research and development; 1.2.4 Cost-effectiveness of pharmaceuticals; 1.2.5 Return on investment; 1.2.6 Probability of success in drug development.

1.2.7 Pharmaceutical crisis1.2.8 Root causes of the pharmaceutical crisis and recommendations for improvement; References; 2 Applications of biomarkers for different purposes in drug development; 2.1 Historical background; 2.1.1 Biomarkers and diagnostics in ancient history; 2.1.2 How revolution made a difference; 2.2 What's a biomarker?; 2.2.1 Published definitions; 2.2.2 Matches and differences between published definitions; 2.2.3 Author's suggested definition; 2.3 Nature of biomarkers and matrix for testing; 2.4 Categories of biomarkers from application perspectives.

2.4.1 Diagnostic biomarker2.4.2 Predictive biomarkers; 2.4.2.1 Susceptibility biomarkers; 2.4.2.2 Prognostic biomarkers; 2.4.2.3 Predictive biomarkers; 2.4.2.4 Pharmacogenetics and pharmacogenomics; 2.4.3 Safety biomarkers; 2.4.3.1 Examples of traditional safety biomarkers; 2.4.3.2 Examples of specialized safety biomarkers; 2.4.4 Surrogate endpoint biomarkers; 2.4.4.1 Basis for a drug approval; 2.4.4.2 Clinical trial endpoint; 2.4.4.3 Value of surrogate endpoints; 2.4.5 Monitoring biomarker; 2.4.6 Pharmacodynamic biomarkers; References; Further reading; 3 Pharmacogenetics of therapeutics.

3.1 Pharmacogenetics and pharmacogenomics3.2 Some key milestones in the road toward pharmacogenetics and pharmacogenomics; 3.3 Pharmacogenetics and pharmacogenomics in drug development; 3.4 Pharmacogenetics and pharmacogenomics on FDA-approved drug labels and package inserts; 3.5 Classes of pharmacogenetics and pharmacogenomics biomarkers with some examples from each class; 3.5.1 Drug transporters; 3.5.1.1 P-glycoprotein; 3.5.1.2 Cystic fibrosis transmembrane conductance regulator; 3.5.2 Pharmacogenetics and pharmacogenomics of drug metabolism.

3.5.2.1 Pharmacogenetics and pharmacogenomics of the oxidative reactions (phase I of drug metabolism)3.5.2.1.1 Cytochrome-P-450 2D6; 3.5.2.1.2 CYP2C19; 3.5.2.1.3 CYP2C9; 3.5.2.1.4 Vitamin K epoxide reductase complex subunit 1; 3.5.2.2 Pharmacogenetics and pharmacogenomics of drug conjugation (phase II of drug metabolism); 3.5.2.2.1 Uridine diphosphate glucuronosyltransferase; 3.5.2.2.1.1 Examples of uridine diphosphate glucuronosyltransferase substrates; 3.5.2.2.1.2 Examples of uridine diphosphate glucuronosyltransferase inhibitors; 3.5.2.2.2 Sulfate (sulfonate) conjugation.

The high failure rate in the pharmaceutical industry has positioned biomarkers and personalized medicine in the frontline, as possible solutions. If executed right, biomarkers and companion diagnostics (CDx) can potentially help the drug industry enhance the probability of success, accelerate the time to market, and, more importantly, benefit patients by supporting accurate diagnosis and selection of the most effective and least toxic therapies. This book aims to examine the challenges and limitations in biomarkers and laboratory tests. It also offers advice on best practices to ensure proper application of biomarkers and bridges the gap between diagnostic business development claims and real-life deliverables. The book covers biomarkers for different purposes, provides examples from different technologies, which includes standard-of-care approved assays as well as for-investigational-use and for-research-use-only assays. It also includes new data for biomarkers in different therapeutic indications and offers case studies and practical examples. This book serves as a reference to drug developers, IVD providers, clinical labs, healthcare givers, academicians, and researchers for best practices to help increase the probability of success in drug development and improve patient management.

Medienart:	E-Book

Erscheinungsjahr:	[2019]
Erschienen:	London: Academic Press ; 2019

Sprache:	Englisch

Beteiligte Personen:	Halim, Abdel [VerfasserIn]

Links:	www.sciencedirect.com [lizenzpflichtig]

ISBN:	978-0-12-816122-7

BKL:

44.40 / Pharmazie / Pharmazeutika

Themen:

Biochemical markers Biomarkers Clinical Laboratory Techniques Diagnostic Techniques and Procedures Diagnostics - M�ethodologie Drug Development Drug Discovery Drug Industry Electronic books HEALTH & FITNESS / Holism HEALTH & FITNESS / Reference Industrie pharmaceutique M�edecine - Laboratoires - Technique M�edecine personnalis�ee MEDICAL / Alternative Medicine MEDICAL / Atlases MEDICAL / Essays MEDICAL / Family & General Practice MEDICAL / Holistic Medicine MEDICAL / Osteopathy Marqueurs biologiques Medical laboratory technology Personalized medicine Pharmaceutical industry Precision Medicine

Anmerkungen:	Includes bibliographical references and index

Umfang:	1 Online-Ressource (282 Seiten)

Förderinstitution / Projekttitel:

PPN (Katalog-ID):	1670513610