Biomarkers, diagnostics and precision medicine in the drug industry : critical challenges, limitations and roadmaps for the best practices /: critical challenges, limitations and roadmaps for the best practices. (2019)

• Record Type: Book
• Further Information: Note: Abdel Halim.
• Authors: Halim, Abdel
• Contents: 1. Drug development crisis 2. Potential role and possible applications of biomarkers in different phases of drug development with examples from different classes of biomarkers 3. Possible role of diagnostics and precision medicine to enhance probability of success in drug development and enhance patient care 4. Attributes of a good biomarker and a diagnostic test 5. Lack of good strategic planning to include biomarkers in a clinical development program with emphasis on intra- and inter-organizational disorientation and conflicts of interest 6. Complexity of biomarker discovery including potential lack of commutability of preclinical models to human trials 7. Inter and intra-subject biological variabilities and its impact on biomarker utility 8. Inconsistency in assay development and validation, and lack or improper operational quality control 9. Preanalytical variables and their possible impact on biomarker results 10. Analytical discrepancies and their imminent risk on drug development and patient care 11. Roadmap and plans for the best practices
• Publisher Details: Amsterdam : Academic Press
• Publication Date: 2019
• Extent: 1 online resource
• Subjects: 615.7; Personalized medicine; Drug development; Biochemical markers -- Diagnostic use
• Languages: English
• ISBNs: 9780128161227
• Related ISBNs: 9780128161210
• Notes: Note: Description based on CIP data; resource not viewed.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.