PRZEDMIOTEM OFERTY JEST KOD DOSTĘPOWY DO KSIĄŻKI ELEKTRONICZNEJ (EBOOK)
KSIĄŻKA JEST DOSTĘPNA NA ZEWNĘTRZNEJ PLATFORMIE. KSIĄŻKA NIE JEST W POSTACI PLIKU.
Principles of Biomedical Sciences and Industry Improve your product development skills to bring new ideas to biomedicine The development of innovative healthcare products, such as biodegradable implants, biopharmaceuticals, or companion diagnostics, requires a multi-disciplinary approach that incorporates scientific evidence with novel and innovative ideas to create new and improved products and treatments. Indeed, product development and the integration of science with commercial aspects have become key challenges for scientists working in the pharmaceutical, biotech, and medtech industries. Using a multi-pronged approach to development, Principles of Biomedical Sciences and Industry combines ideas and methodologies from four of the central areas of focus in the biomedical arena: pharmaceuticals, diagnostics, biomaterials, and medical devices. In doing so, the book covers the entire product lifecycle, from translating a scientific idea into a prototype to product development, launch, and management. Principles of Biomedical Sciences and Industry readers will also find: Several case studies from the most important product categories (pharmaceuticals, diagnostics, medical devices, combination products) Chapters dealing with toxicology and safety risks in development, as well as regulatory approval Key business aspects including how to secure funding, managing intellectual property, and price regulation in the market An ideal resource for teachers and students that conveys the information in an easily-digestible format Ideal for advanced students and young professionals pursuing a career in the biomedical and healthcare industries, Principles of Biomedical Sciences and Industry is an essential reference for those in pharmaceutical industry, biotechnologists, medicinal chemists, bio-engineers, pharma engineers, and management consultants.
- Autorzy: Alexander Schuhmacher
- Wydawnictwo: Wiley Global Research (STMS)
- Data wydania: 2022
- Wydanie: 1
- Liczba stron:
- Forma publikacji: ePub (online)
- Język publikacji: angielski
- ISBN: 9783527824007
BRAK MOŻLIWOŚCI POBRANIA PLIKU. Drukowanie: OGRANICZENIE DO 10 stron. Kopiowanie: OGRANICZENIE DO 2 stron.
- Cover
- Title Page
- Copyright
- Foreword
- About the Editors
- List of Abbreviations
- 1 Biopharmaceutical Innovation at a Glance
- Summary
- 1.1 Biopharmaceutical Innovation and Drug Development, the Past and Present
- 1.2 Why We Wrote This Book and What Readers Can Expect to Gain from Reading It
- References
- 2 Pharmacology and Drug Targets – The Basis of Therapeutics
- Summary
- 2.1 Introduction
- 2.2 Pharmacodynamics
- 2.3 Receptors and Ion Channels
- 2.4 Receptor Agonism and Antagonism
- 2.5 Implications for Drug Development
- 2.6 Pharmacokinetics
- 2.7 Quantitative Pharmacokinetics
- 2.8 Pharmacokinetic Models
- 2.9 Implications for Drug Development
- 2.10 Conclusions
- References
- 3 Principles and Methods of the Pharmaceutical Drug Discovery Process – From Idea over Target to a Development Candidate
- Summary
- 3.1 What is the Purpose of Drug Discovery?
- 3.2 Phases of the Drug Discovery Process
- 3.3 Target Identification
- 3.4 Strategies to Modulate Biological Targets
- 3.5 The Lead Identification Process
- 3.6 Strategies to Identify Lead Compounds
- 3.7 Drug Candidates
- 3.8 Outlook
- References
- 4 Biomarkers: Definitions and Utility for Drug Development
- Summary
- 4.1 Introduction
- 4.2 Biomarker Modalities
- 4.3 Biomarkers in Drug Development
- 4.4 Biomarker Use Cases
- 4.5 Outlook
- References
- 5 Toxicology in Drug Development – Understanding a Drug's Toxicity and Managing Safety and Risks
- Summary
- 5.1 Introduction to Toxicology and Definitions
- 5.2 The General Toxicological Framework
- 5.3 The Concept of the Therapeutic Index
- 5.4 The International Regulatory Framework for Safety Evaluations
- 5.5 Animal Species Selection
- 5.6 Basic Concepts for Non-clinical Studies to Support Clinical Trials
- 5.7 What Activity at Which Stage of Development?
- 5.8 Estimating the Safe Starting Dose in FIH Trials
- 5.9 Toxicological Evaluations During Late-Stage Drug Development
- 5.10 Outlook
- References
- 6 Introduction to Chemistry Manufacturing and Controls – From Compound and Development Candidate to Drug
- Summary
- 6.1 CMC Introduction and Background
- 6.2 Some Basic Thoughts
- 6.3 Preclinical Development and the Clinical Phase 1 from a CMC Perspective
- 6.4 Preclinical Development and the Clinical Phase 2 from a CMC Perspective
- 6.5 Preclinical Development and the Clinical Phase 3 from a CMC Perspective
- 6.6 The Compilation and Authoring of the Submission Dossier for Marketing Authorization
- 6.7 The NDA Submission and the Steps to Product Launch
- References
- 7 Translational Medicine – The Bridging Discipline. Role and Tools in the Drug Development Process
- Summary
- 7.1 Translational Medicine, Definitions and History
- 7.2 The Translational Gap
- 7.3 Paths of Translation
- 7.4 Translational Medicine in Drug Development
- 7.5 Serendipity
- 7.6 Conclusions
- References
- 8 Decision-Making: What are the Key Drivers Around Decision-Making in Drug Development?
- Summary
- 8.1 Background
- 8.2 Key Decision Points
- 8.3 Moving Towards Go IND Enabling’
- 8.4 Moving Towards Go/No Go First in Human (FIH)
- 8.5 Moving Towards Go/No Go Phase 2
- 8.6 Moving Towards Go Confirmatory Development
- 8.7 Concluding Remarks
- References
- 9 Clinical Drug Development – Clinical Characterization for Regulatory Approval
- Summary
- 9.1 Clinical Drug Development, Definition, and Framework
- 9.2 The Different Stages of Clinical Development
- 9.3 The Basic Framework and Elements for Clinical Trials
- 9.4 The Clinical Study Protocol
- 9.5 Written Subject Information
- 9.6 Graphical Study Design and Schedule of Activities
- 9.7 Definition of Patient Population and Sample Size Calculation
- 9.8 Study Design
- 9.9 General Methods and Statistical Tools
- 9.10 Target Product Profile, Clinical Development Plan, and Other Documents During Development
- 9.11 Changing Environment: Sensors, Digitalization, and COVID-19 Pandemic
- 9.12 Key Studies During Clinical Development
- 9.13 Advisory Boards, Steering Committees, Data and Safety Monitoring Boards
- 9.14 Summary of Information
- References
- 10 Regulatory Affairs – Communicating with Health Authorities
- Summary
- 10.1 Regulatory Environment – Getting Started
- 10.2 The Role of Regulatory Affairs in Early Drug Development
- 10.3 The Common Technical Document
- 10.4 Investigational New Drug
- 10.5 Clinical Trial Application
- 10.6 Early Consultations with Health Authorities
- 10.7 Regulatory Requirements for Paediatric Diseases
- 10.8 Regulatory Pathways for Drug Development for Orphan/Rare Diseases
- 10.9 Accelerated Pathways for Expedited Clinical Development and Regulatory Review
- 10.10 The Role of Regulatory Affairs in Late-Stage Drug Development
- 10.11 The Role of Regulatory Affairs Before, During and After Registration
- 10.12 Pre-submission Meetings with Health Authorities
- 10.13 Additional Submission-Enabling Regulatory Affairs Activities
- 10.14 Health Authority Review of Registration Dossiers
- References
- 11 Regulatory Affairs in Device Development – How to Design Medical Devices Capable to Enter the Market
- Summary
- 11.1 Introduction
- 11.2 Product Commercialization
- 11.3 Ten Things to Know and Consider When Developing a Device
- 11.4 Obtaining Qualified Input from Interested Parties
- 11.5 Planning and Executing All Important Development Milestones
- 11.6 Design and Development Verification: Did I MAKE the Product Right?
- 11.7 Design and Development Validation: Did I MAKE the Right Product?
- References
- 12 Market Entry and Reimbursement: Making Drugs Available for Patients After Drug Approval
- Summary
- 12.1 Introduction
- 12.2 Healthcare Challenges
- 12.3 What Does Market Access Mean?
- 12.4 Market Access Gatekeepers
- 12.5 Drug Purchasing
- 12.6 Payers and Value Assessment
- 12.7 Health Economics as a Decision Tool for Market Access
- 12.8 Setting the Right Price
- 12.9 How Does the Pharma Industry Prepare for Market Entries?
- 12.10 Early Patient Access
- 12.11 Managed Entry Agreements
- 12.12 Market Access Trends
- 12.13 Future Market Access Challenges
- References
- Note
- 13 Pricing in Germany – Key Learnings for Optimizing Price Potential After the Introduction of AMNOG
- Summary
- 13.1 Introduction
- 13.2 Structure of the Pricing and Reimbursement Process in Germany
- 13.3 Analysis of Effects of the AMNOG Process on Drug Prices in Germany
- 13.4 Learnings from AMNOG to Ensure Success in the German Market
- 13.5 Study Design
- 13.6 Dossier Preparation
- 13.7 Pre-launch Strategy
- 13.8 Post-launch
- 13.9 Price Negotiation
- 13.10 Post-negotiation
- 13.11 Key Takeaways
- Key Resources
- References
- 14 Project, Risk, and Portfolio Management – Managing R&D Projects Today*
- Summary
- 14.1 Introduction
- 14.2 The Phases of the Pharma R&D Process
- 14.3 Projects and Project Management
- 14.4 Project Life Cycle and Project Phases
- 14.5 Risk Management
- 14.6 Portfolio Management
- References
- Note
- 15 Intellectual Property – How to Protect Innovation in the Biopharmaceutical Industry
- Summary
- 15.1 Introduction to Intellectual Property Rights
- 15.2 Patent Rights
- 15.3 The Freedom to Operate’ Principle
- 15.4 Intellectual Property Protection in the Biopharmaceutical Industry
- 15.5 Conclusion
- 16 Patents in the Biomedical Sciences and Industry – The Case of the Swiss Life Science Company Prionics
- Summary
- 16.1 Patents in the Biomedical Sciences and Industry
- 16.2 The Swiss Life Science Company Prionics
- 16.3 Success Factors and Failures
- 16.4 Consequences and Insights
- Key Resources
- References
- Note
- 17 Pharmaceutical Business Development and Licensing – Overview of a Cross-Functional and Multifaceted Role and Its Key Elements in Biopharmaceutical Industry
- Summary
- 17.1 Introduction
- 17.2 Types of Collaborations
- 17.3 Licensing Agreements
- 17.4 Commercial or Distribution Partnerships
- 17.5 Research Collaborations
- 17.6 Other Types of Agreements
- 17.7 Tech Transfer Agreements
- 17.8 Structured Approach – How to Start a Transaction?
- 17.9 Evaluation Process
- 17.10 Due Diligence
- 17.11 Letter of Intent and Term Sheet
- 17.12 Negotiation and Contract Closure
- 17.13 Alliance Management
- 17.14 Conclusions
- References
- 18 The Entrepreneur's Guide Through the Galaxy of Biotech Funding
- Summary
- 18.1 Introduction
- 18.2 Seed Funding – from a Research Concept to Validation of a Business Idea
- 18.3 Getting Serious – Series A
- 18.4 Getting more Serious – Series B
- 18.5 Venture Debt as an Alternative to a Series B
- 18.6 Getting most Serious – Series C
- 18.7 Exit Options
- 18.8 Closing Remarks
- Reference
- 19 Medical Technologies – Key Learning from Two Case Studies
- 19.1 Case Study 1 – Medical Grade Plastics (MPG)
- 19.2 Case Study 2 – Vitrectomy Using Fast Pneumatic-Driven Cutter Systems
- 19.3 Innovative Valve Technology
- 19.4 Integration Technology
- Note
- 20 Laboratory Diagnostics – Tools for Clinical Decision-Making and Clinical Trial Endpoints
- Summary
- 20.1 Definition of Diagnostics, Why Diagnostics, Importance of Diagnostics, Sample Types
- 20.2 The Diagnostics Industry – Key Figures and Key Players
- 20.3 Brief History of Diagnostics
- 20.4 Elements of the Laboratory Workflow (Pre-analytics, Analytics, and Post-analytics)
- 20.5 Various Types of Diagnostic Tests in the Laboratory
- 20.6 Place of Diagnostics in the Clinical Workflow
- 20.7 Quality Management
- 20.8 Regulatory Approval of Diagnostics
- 20.9 The Diagnostics R&D Process – Stage Gate and Agile Development Processes
- 20.10 The Future of Diagnostics – Key Technologies and Trends, Personalized Diagnostics
- 20.11 Conclusions
- References
- 21 Vaccination: Towards an Improved Influenza Vaccine
- Summary
- 21.1 Influenza – A Deadly Disease with a Long History
- 21.2 The Annual Challenge
- 21.3 Mechanisms of the Immune Response
- 21.4 Antigen Content
- 21.5 Although Influenza Vaccine Formulation Evolves to Reflect the Circulating Strains, Innovation is Rare
- 21.6 Medical Rationale for Intradermal Administration (ID)
- 21.7 Search for Greater Acceptability
- 21.8 Acceptability of the New Device
- 21.9 Acceptability in Real Life
- 21.10 Outlook and Trends
- References
- Index
- End User License Agreement
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