This practical guide to four major areas within the biomedical industry (pharmaceuticals, diagnostics, biomaterials, medical devices) covers the entire product lifecycle, from translating a scientific result into a prototype to product launch and portfolio management.
Biopharmaceutical Innovation at a Glance
Pharmacology and Drug Targets - The Basis of Therapeutics
Principles and Methods of the Pharmaceutical Drug Discovery Process - From Idea over Target to a Development Candidate
Biomarkers - Definitions and Utility for Drug Development
Toxicology and Managaing Safety and Risks
Introduction to Chemistry Manufacturing and Controls - From Compound and Development Candidate to Drug
Translational Medicine - The Bridging Discipline: Role and Tools in the Drug Development Process
Decision-Making - What Are the Key Drivers Around Decision-Making in Drug Development?
Clinical Drug Development - Clinical Characterization for Regulatory Approval
Regulatory Affairs - Communicating with Health Authorities
Regulatory Affairs in Device Development - How to Design Medical Devices Capable to Enter the Market
Market Entry and Reimbursement - Making Drugs Available for Patients After Drug Approval
Pricing in Germany - Key Learnings for Optimising Price Potential After the Introduction of AMNOG
Project, Risk and Portfolio Management - Managing R&D Project Costs and Risks
Intellectual Property - How to Protect Innovation in the Biopharmaceutical Industry
Patents in the Biomedical Sciences and Industry - The Case of Swiss Life Science Company Prionics
Pharmaceutical Business Development & Licensing - Overview of a Cross-functional and Multifaceted Role and Its Key Elements in Biopharmaceutical Industry
The Entrepreneur's Guide Through the Galaxy of Biotech Funding
Medical Technologies - Key Learning from Two Case Studies
Diagnostics - Tools for Clinical Decision Making and Clinical Trial Endpoints
Vaccination - Towards an Improved Influenza Vaccine
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Statement of Responsibility:
edited by Markus HInder, Alexander Schuhmacher, Jörg Goldhahn, Dominik Hartl
Year:
[2022]
Publisher:
Weinheim, Germany, Wiley-VCH
Articles:
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Classification:
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ME-10
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ISBN:
9783527345717
ISBN (2nd):
352734571X
Description:
xxxi, 409 Seiten, Illustrationen
Language:
Englisch
Media group:
Ausleihbestand