PRZEDMIOTEM OFERTY JEST KOD DOSTĘPOWY DO KSIĄŻKI ELEKTRONICZNEJ (EBOOK)
KSIĄŻKA JEST DOSTĘPNA NA ZEWNĘTRZNEJ PLATFORMIE. KSIĄŻKA NIE JEST W POSTACI PLIKU.
Fundamentals of DRUG DEVELOPMENT
Enables readers to understand the process of pharmaceutical research, its regulatory basis, and how it fits into the global healthcare environment
This book discusses how to conduct pharmaceutical research and the context for how the industry fits into global healthcare. Holistically, the well-qualified author helps readers and students of drug development appreciate the time and expense of the process. Specifically, the work identifies the emerging trends shaping the future of drug development, along with important related topics like generic drugs, data sharing, and collaboration.
To aid in seamless reader comprehension, the book includes a glossary of terms and a self-assessment quiz for each chapter at the end. PowerPoint slides are also available as an online ancillary for adopting professors. Sample topics covered in the book include:
- Drug development and its phases
- Decision-making processes, drug development milestones, and compound progression metrics
- The various disciplines involved along with an assessment of the complexity and risks associated across the stages of development
- Differences in the nature and scope of development programs due to the therapeutic area of interest
- Associated costs and resources required
Graduate students and professors teaching courses in drug development, drug discovery, pharmaceuticals, medicinal chemistry, and drug synthesis will be able to use this book as a complete resource for understanding all the complexities and nuances involved in the drug development process.
- Autorzy: Jeffrey S. Barrett
- Wydawnictwo: Wiley Global Research (STMS)
- Data wydania: 2022
- Wydanie: 1
- Liczba stron:
- Forma publikacji: ePub (online)
- Język publikacji: angielski
- ISBN: 9781119691730
BRAK MOŻLIWOŚCI POBRANIA PLIKU. Drukowanie: OGRANICZENIE DO 10 stron. Kopiowanie: OGRANICZENIE DO 2 stron.
- Cover
- Title Page
- Copyright Page
- Dedication Page
- Contributors Biographies
- Preface
- About the Companion Website
- Introduction
- Reference
- 1 The History of Drug Development
- Introduction
- Wild Health and Nature’s Pharmacy
- Traditional Medicine, Traditional Remedies
- Alchemists, Chemists, and Pharmacists
- The Birth of Pharmacy
- Pharmacy Becomes an Industry
- Drug Development in the Modern Era
- References
- Chapter Self-Assessments: Check Your Knowledge
- 2 The Modern Pharmaceutical Industry
- Size and Other Things Matter
- You Are What You Do
- Generics
- Biotech, Biologics, and Biosimilars
- Vaccines
- Nutraceuticals, Natural Products, and Supplements
- Outsourcing and Partnering
- References
- Chapter Self-Assessments: Check Your Knowledge
- 3 Legal Considerations, Intellectual Property,Patents/Patent Protection, and Data Privacy
- Introduction
- The Value Proposition for Drug Development and the Pharmaceutical Industry
- Legal Agreements Supporting the Business of a Pharmaceutical Company
- Due Diligence – How Much to Tell, Share, and Show
- Intellectual Property, Patents, and Patent Protection
- The Modern World of Data Privacy, Protection, and Sharing
- References
- Chapter Self-Assessments: Check Your Knowledge
- 4 Global Regulatory Landscape
- Introduction – The Necessity of Regulation
- The USFDA
- EMA
- PMDA (Japan)
- NMPA (China)
- Everybody Else
- How It Works (or doesn’t) for Drugs
- How it Works for Vaccines
- Harmonization
- References
- Chapter Self-Assessments: Check Your Knowledge
- 5 Phases of Drug Development and Drug Development Paradigms
- Introduction – The Necessity of Establishing Clinical Efficacy and Evolution of Human Phase Testing
- Stages of Development
- The Historical Paradigm
- The Search for Greater Efficiency – Innovation Driving Paradigm Shifts
- New Paradigm Proposals
- The TPP and IPDP
- References
- Chapter Self-Assessments: Check Your Knowledge
- 6 Drug Discovery and Preclinical Development
- Drug Discovery – Introduction
- Product Characterization
- Formulation, Delivery, Packaging Development
- Pharmacokinetics and Drug Disposition
- Pharmacology Testing and Animal Models
- Preclinical Toxicology Testing and IND Application
- Bioanalytical Testing
- Candidate Selection and Ranking Criteria
- The Early TPP
- Milestones for Discovery
- References
- Chapter Self-Assessments: Check Your Knowledge
- 7 Phase 1
- Introduction, Phase 1 Defined
- Who Is Doing What – The Early TPP and Phase 1 Milestones
- Regulatory Hurdles to Human Phase Testing
- Phase 1 Studies
- Phase 1 Economics
- Phase 1 Deliverables Defined
- Toxicology Milestones
- Formulation Development
- Impact of Phase 1 Studies on Labeling
- Phase 1 for Oncology
- Phase 1 for Rare Diseases
- A Successful Phase 1 Program
- References
- Chapter Self-Assessments: Check Your Knowledge
- 8 Phase 2
- Phase 2 Objectives, TPP Alignment and Deliverables to Phase 3
- POC, POP, and POM and the Necessity of Patient and Indication-Specific Biomarkers
- Clinical Endpoint Declaration and Modeling and Simulation
- Phase 2 Study Designs: Common and Novel
- The End of Phase 2A Meeting at FDA
- Exposure Response and the Opportunity for Phase 2 Trials to Support Registration
- Skipping Phase 2
- Phase 2 Attrition
- References
- Chapter Self-Assessments: Check Your Knowledge
- 9 Phase 3
- Efficacy vs. Safety at Phase 3 Dose and Design for the Confirmation
- Patient Population Diversity and Variability
- Efficacy and Safety Endpoints in Phase 3
- Additional Phase 3 Design Considerations
- Statistical Analysis Plan and Pre-specification
- Type One Error Control, Study Power, and the Amount of Evidence for Approval
- Trial Operation Consideration, Enrollment, Monitoring, and Trial Integrity
- Special Protocol Assessment, Fast Track Approval, Success, and Failure
- Patient-centric Consideration, Target Product Profile, and Target Value Profile
- Innovation in Phase 3
- References
- Chapter Self-Assessments: Check Your Knowledge
- 10 Phase 4, Special Populations and Post-marketing
- Definitions – Why are they “Special?”
- Physiology and Regulatory Implications
- Organ (Hepatic and Renal) Impairment
- Pregnant Women
- Pediatrics
- Recommendations for Special Population Trials
- Real-World Evidence
- References
- Chapter Self-Assessments: Check your knowledge
- 11 Role and Function of Project Teams
- Project Team Composition and the Influence of Development Phase
- Terminating Projects and Project Teams
- References
- Chapter Self-Assessments: Check Your Knowledge
- 12 Compound Progression and Go/No Go Criteria
- Introduction – History of Empiricism
- Definitions
- By Phase Criteria
- Decision Theory
- Decision-making within a Company – Process and Interconnectedness
- Impact on Portfolio Prioritization and Planning
- References
- Chapter Self-Assessments: Check Your Knowledge
- 13 Regulatory Milestones and the Submission Process
- Starting at the Finish: Applying for Marketing Authorization
- The Submission Process: United States
- Original IND
- The IND is Continuously Reviewed During Clinical Development
- Regulatory Milestones During Clinical Development
- Types of Meetings
- Timing of Milestone Meetings
- Types of Applications
- Orphan Drug Designation
- Expediting Development and Review of Drugs
- Fast Track Designation
- Breakthrough Therapy Designation
- Standard Review
- Priority Review Designation
- Approval Pathways: Full Approval and Accelerated Approval
- References
- Chapter Self-Assessments: Check Your Knowledge
- 14 Life Cycle Management
- Introduction
- Common Strategies and Strategies Tailored to Certain Product Types
- New Indications – Requirements and Regulatory Considerations
- New Formulations, Combinations, and Over the Counter (OTC) Switch
- Combinations and OTC Switch
- Partnering, Joint Ventures, and Selling Assets
- Drug Repurposing
- Pricing Considerations
- Use Case Examples of Life Cycle Management
- References
- Chapter Self-Assessments: Check Your Knowledge
- 15 Pre-formulation and Formulation Development
- Introduction
- Preformulation
- Formulation of Parenteral Products
- Oral Liquids and Suspensions
- Oral Suspensions
- Oral Solid Tablets and Capsules
- Conclusions
- References
- Chapter Self-Assessments: Check Your Knowledge
- 16 Chemistry, Manufacturing, and Controls
- Introduction
- CMC Definitions and Role in a Pharmaceutical Company
- CMC Personnel and Infrastructure
- IND Activities
- CMC Role During Clinical Phase Development (Phase 1–3)
- NDA Submission and Support
- Scale-up, Batch Size, and Quality Considerations
- Commercial Obligations (Post-NDA) and Supply Chain
- Inspections and Follow-up
- References
- Chapter Self-Assessments: Check Your Knowledge
- 17 Health Economics and the Healthcare Industry
- Introduction
- References
- Chapter Self-Assessments: Check Your Knowledge
- 18 Current State of Affairs
- The Cost of Drug Development
- Probability of Successful Drug Approval by Clinical Study Phase Transition
- Examples of Midphase Success
- Decreasing Efficiency Amidst Scientific Advances
- Increasing Efficiency: Focus on the Biggest Problems First
- Model-Based Drug Development
- PK-PD
- Meta-Analysis
- Design Considerations and Trial Execution Models
- Data-Analytic Models
- Quantitative Decision Criteria and Trial Performance Metrics
- Recent Frontiers and Continued Call to Action
- Integration of Real-World Evidence/Big Data
- References
- Chapter Self-Assessments: Check Your Knowledge
- 19 Medical Devices
- Definition of Medical Device
- History of Medical Device Regulations
- Classification of Medical Devices
- Submission Types and Requirements
- Combination Products
- Summary
- Chapter Self-Assessments: Check Your Knowledge
- Useful Resources
- 20 Supply Chain
- What Is the Supply Chain?
- PLAN
- SOURCE
- MAKE
- DELIVER
- QUALITY
- Patients Are Not Patient
- Configuring the Supply Chain… One Site or Multiple? To Manufacture or to Buy?
- Single or Multiple Sites
- What Manufacturing Network Would You Set Up?
- Customized Drugs
- Drugs for Broad-Scale Treatment
- Make vs. Buy – Another Decision Point
- Contract Manufacturers
- Configuring the Distribution Network to Have the Right Product, at the Right Place, at the Right Time
- Close Patient Connection – Using a Distributor
- Product Availability and Cost
- Case Study: The Impact of a Global Pandemic on the Supply Chain
- The Best Supply Chains
- Conclusion
- References
- Chapter Self-Assessments: Check Your Knowledge
- 21 Sales, Marketing and Advertising
- Introduction
- Definitions and Context for Pharmaceutical Sales
- Pharmaceutical Sales and Marketing: Historical and Current Practices
- Advertising
- Legislation and Regulation
- Surveillance and Consequences of False and Misleading Promotion
- Summary
- References
- Chapter Self-Assessments: Check Your Knowledge
- 22 Generic Drugs and the Generic Industry
- Introduction
- New vs. Generic Drugs
- Generic Drug Requirements
- Conclusions
- References
- Chapter Self-Assessments: Check Your Knowledge
- 23 The Generic Drug Approval Process
- Introduction
- ANDA Pathway
- The Orange Book
- First-to-File
- FDA Interactions
- Submission and Content
- Module 1 – Administrative Including Labeling
- Module 2
- Module 3 – Quality (Chemistry, Manufacturing, and Controls)
- Module 4 – Nonclinical
- Module 5 – Clinical
- Submission Fees and Approval Timelines
- References
- Chapter Self-Assessments: Check Your Knowledge
- 24 Data Sharing and Collaboration
- The Pharmaceutical Industry’s History of Collaboration
- Current Collaboration Landscape: Who, How and Why?
- Data Sharing Considerations: Motivations and Incentives
- Technology
- Collaboration Examples
- The Case Against Data Sharing
- Data Sharing for the Future
- References
- Chapter Self-Assessments: Check Your Knowledge
- 25 The Future of the Pharmaceutical Industry
- How We Got Here and Why We Cannot Sustain It
- Relevant Trends
- The Case for Change
- One Possible Future
- References
- Chapter Self-Assessments: Check Your Knowledge
- Glossary
- Self-Assessment Quiz Answers
- Index
- End User License Agreement
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