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Developing Solid Oral Dosage Forms

Pharmaceutical Theory and Practice

  • 2nd Edition - November 8, 2016
  • Newer edition is available
  • Editors: Yihong Qiu, Yisheng Chen, Geoff G.Z. Zhang, Lawrence Yu, Rao V. Mantri
  • Language: English

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products… Read more

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Description

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations.

This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process.

New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more.

Key features

  • Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings
  • Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more
  • Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

Readership

Pharmaceutical researchers in industry and at academic institutions focused on developing solid dosage forms for drug delivery; professors and students involved in advanced graduate level courses in pharmaceutical sciences programs

Table of contents

  • Dedication
  • List of Contributors
  • Part I: Theories and Techniques in the Characterization of Drug Substances and Excipients
    • Chapter 1. Solubility of Pharmaceutical Solids
      • Abstract
      • 1.1 Introduction
      • 1.2 Thermodynamics of Solutions
      • 1.3 Theoretical Estimation of Solubility
      • 1.4 Solubilization of Drug Candidates
      • 1.5 Experimental Determination of Solubility
      • References
    • Chapter 2. Crystalline and Amorphous Solids
      • Abstract
      • 2.1 Introduction
      • 2.2 Definitions and Categorization of Solids
      • 2.3 Thermodynamics and Phase Diagrams
      • 2.4 Pharmaceutical Relevance and Implications
      • 2.5 Transformations Among Solids
      • 2.6 Methods of Generating Solids
      • 2.7 Amorphous Drugs and Solid Dispersions
      • 2.8 Special Topics
      • References
    • Chapter 3. Solid-State Characterization and Techniques
      • Abstract
      • 3.1 Introduction
      • 3.2 Microscopy
      • 3.3 Powder X-ray Diffraction
      • 3.4 Thermal Analysis
      • 3.5 Vibrational Spectroscopy
      • 3.6 Moisture Sorption
      • 3.7 Hyphenated Techniques
      • 3.8 Conclusion
      • References
    • Chapter 4. API Solid-Form Screening and Selection
      • Abstract
      • 4.1 Introduction
      • 4.2 Solid-Form Selection Considerations
      • 4.3 Screening SOLID-FORMS of API
      • 4.4 Identification and Analysis of Forms
      • 4.5 Conclusions
      • 4.6 Case Studies
      • References
    • Chapter 5. Drug Stability and Degradation Studies
      • Abstract
      • 5.1 Introduction
      • 5.2 Chemical Stability
      • 5.3 Common Pathways of Drug Degradation
      • 5.4 Experimental Approaches to Studying the Chemical Degradation of Drugs
      • 5.5 Physical Stability and Phase Transformations
      • 5.6 Phase Transformations During Pharmaceutical Processing
      • References
    • Chapter 6. Excipient Compatibility and Functionality
      • Abstract
      • 6.1 Introduction
      • 6.2 Excipient Functionality
      • 6.3 Excipient Compatibility
      • 6.4 Excipient Variability
      • 6.5 Risk Assessment of Drug-Excipient Incompatibilities and Mitigation Strategies
      • 6.6 Conclusions
      • References
    • Chapter 7. Polymer Properties and Characterization
      • Abstract
      • 7.1 Introduction
      • 7.2 Basic Concepts and Characterization of Polymeric Materials
      • 7.3 Commonly Used Polymer Excipients in Solid Oral Products
      • 7.4 Conclusion
      • References
    • Chapter 8. Interfacial Phenomena
      • Abstract
      • 8.1 Interfaces
      • 8.2 Fundamental Intermolecular Forces
      • 8.3 Thermodynamics of Particles in Electrolyte Solutions
      • 8.4 Surface Tension and Surface Energy
      • 8.5 Thermodynamics of Wetting
      • 8.6 Solid–Vapor Interface
      • 8.7 Interfacial Phenomenon (Solid–Solid)
      • 8.8 Future Directions—Opinions
      • References
    • Chapter 9. Fundamental of Diffusion and Dissolution
      • Abstract
      • 9.1 Fundamental of Diffusion
      • 9.2 Fundamentals of Dissolution
      • References
    • Chapter 10. Particle, Powder, and Compact Characterization
      • Abstract
      • 10.1 Introduction
      • 10.2 Particle Size Characterization
      • 10.3 Powder Characterization
      • 10.4 Compact (Mechanical Property) Characterization
      • 10.5 Conclusions
      • References
  • Part II: Biopharmaceutical and Pharmacokinetic Evaluations of Drug Molecules and Dosage Orms
    • Chapter 11. Oral Absorption Basics: Pathways and Physicochemical and Biological Factors Affecting Absorption
      • Abstract
      • 11.1 Barriers to Oral Drug Delivery
      • 11.2 Pathways of Drug Absorption
      • 11.3 Pathways of Drug Metabolism
      • 11.4 Pathways of Drug Elimination
      • 11.5 Coupling of Enzymes and Efflux Transporters
      • 11.6 Regulation of Transporters and Enzymes by Nuclear Receptors
      • 11.7 Physicochemical Factors Affecting Drug Absorption
      • 11.8 Biological Factors Affecting Drug Absorption
      • References
    • Chapter 12. Oral Drug Absorption: Evaluation and Prediction
      • Abstract
      • 12.1 Introduction
      • 12.2 Anatomy and Physiology of the GI Tract
      • 12.3 Biopharmaceutics Classification System
      • 12.4 Intestinal Permeability Evaluation: Cultured Cells
      • 12.5 Intestinal Permeability Evaluation: Ex Vivo
      • 12.6 In Silico Methods
      • 12.7 In Vivo Methods to Determine Oral Drug Absorption
      • 12.8 Food Effects on Drug Intestinal Absorption
      • 12.9 Regional Drug Absorption Along GI
      • 12.10 Future Trends
      • 12.11 Conclusions
      • Disclaimer
      • References
    • Chapter 13. Dissolution Testing of Solid Products
      • Abstract
      • 13.1 Introduction
      • 13.2 Theory of Dissolution Test for Solid Drug Products
      • 13.3 Current Technology and Instrumentation for Dissolution Testing
      • 13.4 Regulatory Considerations
      • 13.5 Summary
      • References
    • Chapter 14. Bioavailability and Bioequivalence
      • Abstract
      • 14.1 General Background
      • 14.2 Definitions and Key Concepts
      • 14.3 General Components of BA and BE Studies
      • 14.4 Data Analysis for BA and BE Studies
      • 14.5 Special Topics for BA and BE Assessment
      • 14.6 Biowaiver and BCS
      • 14.7 Summary and Future Perspectives
      • References
    • Chapter 15. Predictive Biopharmaceutics and Pharmacokinetics: Modeling and Simulation
      • Abstract
      • 15.1 Introduction
      • 15.2 Modeling and Simulation Approaches for Biopharmaceutics and PK
      • 15.3 Application of Biopharmaceutics and PK Modeling and Simulation in Drug Development
      • 15.4 Application of Biopharmaceutics and PK Modeling and Simulation in Regulatory Activities
      • 15.5 Summary
      • References
    • Chapter 16. In Vitro/In Vivo Correlations: Fundamentals, Development Considerations, and Applications
      • Abstract
      • 16.1 Introduction
      • 16.2 Development and Assessment of an IVIVC
      • 16.3 Considerations in IVIVC Development
      • 16.4 IVIVC Development Approach
      • 16.5 Applications and Limitations
      • 16.6 Case Studies
      • 16.7 Summary
      • References
  • Part III: Design, Development and Scale-Up of Formulation and Manufacturing Process
    • Chapter 17. Oral Formulations for Preclinical Studies: Principle, Design, and Development Considerations
      • Abstract
      • 17.1 Introduction
      • 17.2 Considerations in Designing Formulations for Preclinical Species
      • 17.3 Use of API Properties to Guide Formulation Design
      • 17.4 Formulations for BCS Class I/III Compounds
      • 17.5 Formulations for BCS Class II/IV Compounds Using Enabling Technologies
      • 17.6 Evaluating Formulation Performance by In Vitro Dissolution
      • 17.7 Rationale Selection of Formulations Suitable for Intended Studies
      • 17.8 Case Study
      • Acknowledgments
      • References
    • Chapter 18. Rational Design for Amorphous Solid Dispersions
      • Abstract
      • 18.1 Introduction
      • 18.2 Key Components of Amorphous Solid Dispersions
      • 18.3 Characterization of Amorphous Dispersions
      • 18.4 Screening and Selection of Amorphous Solid Dispersions
      • 18.5 Stability Considerations
      • 18.6 Solubility and Dissolution Considerations
      • 18.7 Methods of Manufacturing Amorphous Solid Dispersions
      • 18.8 Dosage Form Development Considerations
      • 18.9 Case Studies
      • 18.10 Conclusions
      • References
    • Chapter 19. Rational Design of Oral Modified-Release Drug Delivery Systems
      • Abstract
      • 19.1 Introduction
      • 19.2 Oral MR Technologies and Drug Delivery Systems
      • 19.3 Rational Design of Modified Release Systems
      • 19.4 Summary
      • References
    • Chapter 20. Product and Process Development of Solid Oral Dosage Forms
      • Abstract
      • 20.1 Introduction
      • 20.2 Development of Solid Dosage Forms
      • 20.3 Technology Transfer
      • 20.4 Case Studies
      • 20.5 Intellectual Property Considerations
      • 20.6 Summary
      • References
    • Chapter 21. Analytical Development and Validation for Solid Oral Dosage Forms
      • Abstract
      • 21.1 Analytical Method Development and Validation Strategy
      • 21.2 Category of Analytical Method and Method Development
      • 21.3 Analytical Method Validation
      • 21.4 Method Transfers
      • 21.5 Case Studies
      • 21.6 Conclusions
      • References
    • Chapter 22. Statistical Design and Analysis of Long-Term Stability Studies for Drug Products
      • Abstract
      • 22.1 Stability Study Objectives
      • 22.2 Regulatory Guidance
      • 22.3 Test Methods and Data Management
      • 22.4 Modeling Instability
      • 22.5 Long-Term Stability Study Design
      • 22.6 Determination of Shelf Life
      • 22.7 Release Limit Estimation
      • 22.8 Probability of Future OOS Stability Test Results
      • Appendix A Sample Data
      • References
    • Chapter 23. Packaging Selection for Solid Oral Dosage Forms
      • Abstract
      • 23.1 Introduction
      • 23.2 Material Considerations
      • 23.3 Linking Packaging Property With Drug Property
      • 23.4 Postapproval Packaging Changes
      • References
    • Chapter 24. Clinical Supplies Manufacture: Strategy, GMP Considerations, and Cleaning Validation
      • Abstract
      • 24.1 Introduction
      • 24.2 Strategy of Clinical Supplies Manufacture
      • 24.3 Clinical Plan
      • 24.4 Clinical Supplies Liaison
      • 24.5 Lean Manufacturing
      • 24.6 Cross-Functional Training
      • 24.7 Outsourcing of Manufacturing and Packaging
      • 24.8 New Technology
      • 24.9 GMP Considerations on Manufacturing Clinical Supplies
      • 24.10 Cleaning Validation and Verification
      • 24.11 Case Study
      • 24.12 Summary
      • Acknowledgments
      • References
    • Chapter 25. Specification Setting and Manufacturing Process Control for Solid Oral Drug Products
      • Abstract
      • 25.1 Introduction
      • 25.2 Specifications for the Drug Substance
      • 25.3 Specifications for Clinical Trial Materials
      • 25.4 Specifications for Commercial Drug Products
      • 25.5 Process Control for Solid Oral Drug Products
      • 25.6 Analytical Procedures
      • 25.7 Conclusions
      • Acknowledgments
      • References
    • Chapter 26. Process Development, Optimization, and Scale-Up: Providing Reliable Powder Flow and Product Uniformity
      • Abstract
      • 26.1 Introduction
      • 26.2 Common Powder Handling Equipment
      • 26.3 Typical Flow and Segregation Concerns
      • 26.4 Measurement of Flow Properties
      • 26.5 Basic Equipment Design Techniques
      • References
    • Chapter 27. Capsules Dosage Form: Formulation and Manufacturing Considerations
      • Abstract
      • 27.1 Introduction—Capsules as a Dosage Form
      • 27.2 Gelatin and Capsule Shell Composition
      • 27.3 Capsule Shell Manufacturing
      • 27.4 Alternatives to Gelatin
      • 27.5 Hard Shell
      • 27.6 Capsule Filling
      • 27.7 Capsule Formulation Requirements
      • 27.8 Capsule Formulations
      • References
    • Chapter 28. Design, Development, and Scale-Up of the High-Shear Wet Granulation Process
      • Abstract
      • 28.1 Introduction
      • 28.2 Rate Processes in Wet Granulation
      • 28.3 Material Properties in Wet Granulation
      • 28.4 Design of the Pharmaceutical Wet Granulation Process
      • 28.5 Quality Attributes of Wet Granulated Products
      • 28.6 Scale-Up of the High-Shear Wet Granulation Process
      • 28.7 Modeling and Simulation in High-Shear Wet Granulation
      • 28.8 Summary
      • References
    • Chapter 29. Process Development, Optimization, and Scale-Up: Fluid-Bed Granulation
      • Abstract
      • 29.1 Overview of the Fluid-Bed Granulation Process
      • 29.2 Equipment Design
      • 29.3 Fluid-Bed Hydrodynamics
      • 29.4 Mechanisms of Agglomeration
      • 29.5 Formulation and Process Variables and Their Control
      • 29.6 Scale-Up Considerations
      • 29.7 Application of Quality-by-Design to Fluid-Bed Granulation
      • 29.8 Summary
      • References
    • Chapter 30. Formulation, Process Development, and Scale-Up: Spray-Drying Amorphous Solid Dispersions for Insoluble Drugs
      • Abstract
      • 30.1 Introduction
      • 30.2 Background
      • 30.3 SDD Formulation Composition
      • 30.4 SDD Process Considerations: Manufacturing and Scale-Up
      • 30.5 SDD Characterization
      • 30.6 Dosage Form Considerations
      • 30.7 Concluding Remarks
      • References
    • Chapter 31. Process Development and Scale-Up: Twin-Screw Extrusion
      • Abstract
      • 31.1 Introduction
      • 31.2 Twin-Screw Extruder and Extrusion Process
      • 31.3 Hot-Melt Extrusion
      • 31.4 Continuous Granulation Using a Twin-Screw Extruder
      • 31.5 Process Scale-Up
      • 31.6 Case Studies
      • 31.7 Summary
      • References
    • Chapter 32. Development, Scale-Up, and Optimization of Process Parameters: Roller Compaction Theory and Practice
      • Abstract
      • 32.1 Introduction
      • 32.2 In-Process Analytical Characterization Tools
      • 32.3 Roller Compaction Models
      • 32.4 Approaches to Developing a Roller Compaction Process
      • 32.5 Illustrative Example Detailing the Typical Drug Product Development Process for a Roller Compacted Product
      • 32.6 Scale-Up Considerations of Roller Compaction
      • 32.7 Illustrative Example Detailing a Possible Approach to Scaling-Up a Roller Compaction Process
      • 32.8 Trouble-Shooting
      • 32.9 Conclusions
      • References
    • Chapter 33. Development, Optimization, and Scale-Up of Process Parameters: Tablet Compression
      • Abstract
      • 33.1 Introduction
      • 33.2 Operation Principles of Compression by Rotary Press
      • 33.3 Tool Design
      • 33.4 Tablet Designs
      • 33.5 Care of Punches and Dies
      • 33.6 Tooling Inspection
      • 33.7 Tooling Reworking
      • 33.8 Press Wear
      • 33.9 Purchasing Tablet Compression Tooling
      • 33.10 Consideration of Tooling
      • 33.11 Application of Quality by Design and Tools (Case Study)
      • 33.12 Scale-Up of Compression
      • References
    • Chapter 34. Development, Optimization, and Scale-Up of Process Parameters: Pan Coating
      • Abstract
      • 34.1 Introduction
      • 34.2 Film-Coating Formulations
      • 34.3 Design and Development of Film-Coating Processes
      • 34.4 Troubleshooting
      • 34.5 Consideration of Product Substrate
      • 34.6 Coating Formulation
      • 34.7 Application of Systematic and Statistical Tools for Trouble Shooting and Process Optimization
      • References
    • Chapter 35. Development, Optimization, and Scale-Up of Process Parameters: Wurster Coating
      • Abstract
      • 35.1 Introduction
      • 35.2 Basic Design
      • 35.3 HS Wurster Considerations
      • 35.4 Coating and Process Characteristics
      • 35.5 Processing Examples
      • 35.6 Process Variables
      • 35.7 Case Studies for Layering and Fine Particle Coating
      • 35.8 Scale-Up of Wurster Processing
      • 35.9 Summary
    • Chapter 36. Commercial Manufacturing and Product Quality
      • Abstract
      • 36.1 Introduction
      • 36.2 Process Design, Understanding, and Control Strategy Development
      • 36.3 Process Scale-up, Technology Transfer, and Process Qualification
      • 36.4 Continued Process Verification
      • 36.5 Summary
      • References
    • Chapter 37. Emerging Technology for Modernizing Pharmaceutical Production: Continuous Manufacturing
      • Abstract
      • 37.1 Introduction
      • 37.2 Challenges for Pharmaceutical Manufacturing
      • 37.3 The Adoption of Emerging Technology to Address Pharmaceutical Manufacturing Challenges
      • 37.4 Technologies for Continuous Drug Product Manufacturing
      • 37.5 Challenges in Implementing Continuous Manufacturing
      • 37.6 Conclusion
      • References
  • Part IV: Regulatory Aspects of Product Development
    • Chapter 38. Drug Product Approval in the United States and International Harmonization
      • Abstract
      • 38.1 Drug Product Approval and the US Food and Drug Administration
      • 38.2 The New Drug Application Process
      • 38.3 The Abbreviated New Drug Application Process
      • 38.4 The Biologic License Application Process
      • 38.5 Postapproval Activities and Life Cycle Management of NDAs, ANDAs, and BLAs
      • 38.6 Global Perspectives on Product Registration and Drug Approval
      • Acknowledgments
      • References
    • Chapter 39. Modern Pharmaceutical Regulations: Quality Assessment for Drug Substances
      • Abstract
      • 39.1 Introduction
      • 39.2 Origin of the QbR
      • 39.3 Evolution of the Drug Substance Review Process
      • 39.4 Quality Assessment for Drug Substances
      • 39.5 Conclusion
      • Appendix QbR Questions—Drug Substance
      • References
    • Chapter 40. Modern Pharmaceutical Regulations: Quality Assessment for Drug Products
      • Abstract
      • 40.1 Introduction
      • 40.2 QbR History
      • 40.3 Current Status of QbR
      • 40.4 QbR Questions
      • 40.5 Future Direction
      • 40.6 Conclusions
      • Appendix: QbR Questions
      • References
  • Index

Product details

About the editors

YQ

Yihong Qiu

Dr. Yihong Qiu currently serves as a technical advisor to pharmaceutical companies globally, providing a broad range of scientific expertise, technical know-how, and training across product and process development, regulatory filing, and commercial manufacturing. Prior to 2023, Dr. Qiu was a Senior Research Fellow in Formulation Sciences at AbbVie, where he spent over 30 years at Abbott and AbbVie. His expertise and experience covered the full drug product lifecycle, including preformulation, biopharmaceutics, pharmacokinetics, drug delivery research, product and process development, scale-up, technology transfer, manufacturing troubleshooting, regulatory filing, and intellectual property. His work has led to numerous successful products and processes, patented technologies, in vitro–in vivo correlations (IVIVC), and biowaivers. Dr. Qiu’s research interests include modified-release drug delivery, dissolution, enhancement of oral bioavailability, IVIVC development, and science-based regulatory approaches. He is an elected Fellow of the American Association of Pharmaceutical Scientists (AAPS) and has authored more than 70 publications in journals and books, holds over 40 granted or pending patents, provides training lectures on various aspects of product development, and has delivered numerous invited presentations at conferences. He earned his B.S. in Pharmacy and M.S. in Pharmaceutics from China Pharmaceutical University, and his Ph.D. in Pharmaceutics from the University of Iowa.

Affiliations and expertise
Founder and Chief Technical Director, QPD Solutions, Lincolnshire, IL, USA

YC

Yisheng Chen

Dr. Yisheng Chen is the Senior Vice President of Product Development at Novast Laboratories, Ltd., where he oversees the development of pharmaceutical products for global markets. He earned his Ph.D. in Pharmaceutics from the University of Iowa in 1994 and began his career at Burroughs Wellcome as a development scientist. He later joined Abbott Laboratories, rising through positions of increasing responsibility and being elected Associate Research Fellow of the Volwiler Society. Dr. Chen is recognized for his deep expertise in solid oral pharmaceutical development, spanning formulation and process design, CMC documentation for regulatory submissions, scale‑up, and commercial validation. His technical strengths include quality‑by‑design (QbD) approaches for solid oral dosage forms, with particular emphasis on modified‑release (MR) products. He has led the development and approval of numerous products in the U.S., EU, Japan, and China, including NDAs and complex, high‑barrier ANDAs. Dr. Chen has extensive experience with Wurster coating technology in the development, scale‑up, and troubleshooting of bead‑coating processes. He is widely known for his contributions to packaging protection for drug products. His theoretical model for predicting moisture uptake in packaged products provided the scientific foundation for ASTM D7709 and informed revisions to the USP general chapter on water vapor transmission rate (WVTR). His work also established the scientific rationale for evaluating container performance using MVTR per unit product. Dr. Chen has published more than 30 peer‑reviewed articles, book chapters, and patents. He has served as an expert member of the Product Quality Research Institute (PQRI) and the USP Performance Testing Expert Panel, and he has been an adjunct professor at Guangdong Pharmaceutical University. He is a frequent speaker at national and international conferences and at major universities.

Affiliations and expertise
Senior Vice President, Novast Laboratories, Ltd., Nantong, China

GZ

Geoff G.Z. Zhang

Dr. Geoff G. Z. Zhang, FAAPS, is the Founder and Chief Technical Director of ProPhysPharm; an adjunct professor of the Department of Industrial and Molecular Pharmaceutics at Purdue University; and a Fellow of American Association of Pharmaceutical Scientists. He has contributed broadly to Physical Pharmacy, specifically in the areas of salt and polymorph screening, co-crystallization and crystal engineering, characterization and crystallization of amorphous solids, physical chemistry of supersaturated solutions and the design of amorphous solid dispersions. He has published over 130 peer-reviewed articles, reviews, and book chapters; given 80 invited talks at conferences, universities, pharmaceutical companies, and FDA; and presented more than 150 posters. Prior to founding ProPhysPharm in 2024, he spent 26 years at Abbott/AbbVie. He is a co-inventor of over 170 patents/applications including composition of matter, crystal form, formulation, processing, and method of use on clinical candidates and marketed products. He received his B.Sc. in Physical Chemistry from Fudan University, and Ph.D. in Pharmaceutics from University of Minnesota Twin Cities.

Affiliations and expertise
Founder and Chief Technical Director, ProPhysPharm, Lincolnshire, IL, USA

LY

Lawrence Yu

Dr. Lawrence X. Yu, is an adjunct professor at the University of Michigan and Associate Editor of The AAPS Journal. Dr. Yu has made transformative contributions to pharmaceutical science and regulation. He developed the Compartmental Absorption and Transit (CAT) model, which became the scientific foundation for commercial simulation platforms including GastroPlus™ and Simcyp®. As chair of FDA's Biopharmaceutics Classification System (BCS) Committee from 2000 to 2016, he advanced global acceptance of BCS and contributed to the 2019 ICH M9 guideline. He pioneered Pharmaceutical Quality by Design (QbD) as a regulatory paradigm, emphasizing design, understanding, control, and lifecycle management. Most recently, he originated the Knowledge-aided Assessment and Structured Applications (KASA) initiative to strengthen knowledge management and enable artificial intelligence in regulatory decision-making. Dr. Yu currently leads the ICH Expert Working Group revising the M4Q(R1) guideline to modernize pharmaceutical product registration and lifecycle management. He has authored over 178 scientific publications, delivered more than 400 invited presentations, and co-edited three influential books on biopharmaceutics and drug development.

Affiliations and expertise
Adjunct Professor, Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA

RM

Rao V. Mantri

Dr. Rao V. Mantri is the Chief Manufacturing Officer (CMfgO) at Astellas. Under his leadership, Astellas continues to accelerate product development through launch and ensure a reliable supply, leveraging innovative capabilities across modalities. Rao brings more than 24 years of leadership and experience across the pharmaceutical value chain, including global product development, manufacturing and supply chain management during his tenure at Bristol Myers Squibb. Over his career, he has contributed to the development and commercialization of many innovative pharmaceutical and biologic products. Rao received his B.Tech. in Chemical Engineering from Osmania University, India, M.S. in Chemical Engineering, M.S., and Ph.D.(honors) in Pharmaceutical Chemistry from The University of Kansas, USA. He also holds Executive MBA from MIT Sloan. Rao authored 30 peer-reviewed publications, 13 patents/applications and delivered numerous Keynote/Invited lectures. He also served on USP Expert Committee and was industrial mentor for NSF ERC. Rao’s strong expertise across modalities and technologies is complemented by his strategic insights, focused execution, and ability to build across cultures and functions. He is committed to creating and delivering innovative medicines to patients around the world, with a sense of urgency.

Affiliations and expertise
Chief Manufacturing Officer, Astellas Pharma Inc. Northbrook, IL, USA, USA

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