Developing Solid Oral Dosage Forms

Pharmaceutical Theory and Practice

2nd Edition - November 8, 2016
Editors: Yihong Qiu, Yisheng Chen, Geoff G.Z. Zhang, Lawrence Yu, Rao V. Mantri
Language: English
Hardback ISBN:
9 7 8 - 0 - 1 2 - 8 0 2 4 4 7 - 8
eBook ISBN:
9 7 8 - 0 - 1 2 - 8 0 2 6 3 7 - 3

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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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.

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

Yihong Qiu

Dr. Yihong Qiu is currently a Senior Research Fellow, Oral Drug Products, Science and Technology, AbbVie. His in-depth knowledge and extensive experience encompass various phases of product development, including preformulation, drug delivery technology, product/process design, biopharmaceutics/pharmacokinetics, formulation/process development, scale-up and optimization, manufacturing trouble-shooting, intellectual property and regulatory registration for NCE’s, line-extension and marketed products. He also plays a key role in the product life cycle management, IP strategy, scientific and regulatory assessment of business opportunities. During his 25-year tenure with Abbott/AbbVie, his work has resulted in successful commercial IR and MR products, patented drug delivery technologies, IVIVC’s and biowaivers approved by global regulatory agencies. Dr. Qiu’s research interests include modified-release delivery systems, dissolution, bioavailability, IVIVC, drug delivery technology and science-based regulation. He is an elected fellow of the American Association of Pharmaceutical Scientists (AAPS), a member of 2010-2015 USP Expert Committee and a review committee member of Chang Jiang Scholars Program (2014-15). He has more than 50 publications in journals and books, 30 patents granted or pending, and numerous invited presentations. He is routinely invited to lecture at professional organizations and universities. Dr. Qiu received BS in Pharmacy, MS. in Pharmaceutics from China Pharmaceutical University, and Ph.D. in Pharmaceutics from The University of Iowa.

Affiliations and expertise

PhD, Senior Research Fellow, Oral Drug Products, Manufacturing Science and Technology, AbbVie Inc., North Chicago, IL, USA

Yisheng Chen

Dr. Yisheng Chen currently serves as Vice President of Product Development at Novast Laboratories, Ltd, leading the development of pharmaceutical products for global markets. Dr. Chen earned his Ph.D. degree in Pharmaceutics in 1994 from the University of Iowa. He then joined Burroughs Wellcome as a development scientist, and later Abbott Laboratories with increasing responsibilities where he was elected as an Associate Research Fellow, Volwiler Society. Dr. Chen also served as an expert member of both the Product Quality Research Institute (PQRI) and the USP Performance Testing Expert Panel, and as an adjunct professor at the Guangdong Pharmaceutical University. Dr. Chen has in-depth knowledge and extensive experience in various aspects of developing solid pharmaceutical products, ranging from formulation and process development, CMC documentation for regulatory filing, scale-up, and validation for commercialization. His expertise includes the quality by design (QbD) development of modified release (MR) products using traditional delivery technologies, and development of new delivery systems for MR products. Dr. Chen has extensive experience in the development and scale-up of beads coating process using Wurster coating technology for different types of products from lab to commercial scales. He has successfully led the development and secured the approval of more than 30 products approved in the US, EU, Japan and China, including new drug applications (NDAs) and high barrier branded abbreviated new drug applications (ANDAs). Dr. Chen also has the expertise in packaging protection of drug products. He developed a theoretical model for predicting moisture uptake by packaged products during storage. His theory provided the fundamental basis for the development of ASTM D7709 and the revision of USP general chapter on the standard methods for measuring the water vapor transmission rate (WVTR) of containers, as well as the scientific criteria of using MVTR/unit product to evaluate the performance of containers for product protection. Dr. Chen has published over 30 peer-reviewed articles, book chapters, and patents. He is a co-editor of “Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice”. Dr. Chen is a frequent speaker at national and international conferences, and at major universities.

Affiliations and expertise

Vice President, Novast Laboratories, Nantong, China

Geoff G.Z. Zhang

Dr. Geoff G. Z. Zhang is a Senior Research Follow at AbbVie Inc., an adjunct professor of the Department of Industrial and Physical Pharmacy at Purdue University, and a Fellow of the American Association of Pharmaceutical Scientists. He received his B.Sc. in Physical Chemistry from Fudan University, China, and Ph.D. in Pharmaceutics from the University of Minnesota, USA. He has contributed broadly to Physical Pharmacy, specifically in the areas of crystal engineering, polymorphism, characterization and crystallization of amorphous solids and amorphous solid dispersions, as well as delivery of poorly water soluble compounds. He has published over 70 peer-reviewed articles, reviews, and book chapters, given over 170 podium and poster presentations. During his 18-year tenure with Abbott/AbbVie, he has more than 120 granted patents and patent applications. He interacts and collaborates extensively with academic institutes and has mentored 40 graduate students on their thesis and summer research projects. He has received 2012 AAPS Pharmaceutical Research Meritorious Manuscript Award, and serves on the United State Pharmacopeia Physical Analysis Expert Committee.

Affiliations and expertise

Senior Research Fellow, Drug Product Development, Abbvie, Inc., North Chicago, IL, USA

Lawrence Yu

Lawrence X. Yu, Ph.D., is the Deputy Director, Office of Pharmaceutical Quality, Food and Drug Administration, where he oversees new, generic, and biotechnology product quality review and inspection functions as well as the FDA CDER quality labs. He is also adjunct Professor of Pharmaceutical Engineering at the University of Michigan. Prior to joining the FDA, Dr. Yu had worked at Pfizer (Upjohn) and GlaxoWellcome for 8 years. Dr. Yu joined the FDA in 1999 and has served as Team Leader, Deputy Division Director, Division Director, Deputy Office Director, and Office Director. Dr. Yu’s research interests have centered on the prediction of oral drug delivery and the development of pharmaceutical Quality by Design. His compartmental absorption and transit (CAT) model has laid the foundation for the commercial software, GastroPLUSTM and Simcyp®, which are being widely used in the pharmaceutical industry. Dr. Yu is a fellow and the past section Chair of the American Association of Pharmaceutical Scientists and an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored over 140 papers, and presented over 100 abstracts, and given over 200 invited presentations. He is a co-editor of the books entitled “Biopharmaceutics Applications in Drug Development , “FDA Bioequivalence Standards , and “Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, 2nd Ed. Dr. Yu is the winner of numerous awards including AAiPS distinguished Scientist Award, AAPS Regulatory Science Achievement award, AIChE PD2M Drug Product QbD Achievement Award, Japan Naigai Foundation Distinguished Lectureship, China Beijing University IPEM graduation commencement address, Department of Health and Human Service Outstanding Leadership Award, FDA Commissioner’s Special Citation, Outstanding Achievement, Group Recognition, and Team Excellence awards.

Affiliations and expertise

Deputy Director, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Rao V. Mantri

Dr. Rao V. Mantri is currently working as Executive Director in Drug Product Science & Technology at Bristol-Myers Squibb Company. He received his B.Tech. in Chemical Engineering from Osmania University, India, M.S. in Chemical Engineering, M.S. in Pharmaceutical Chemistry and Ph.D. in Pharmaceutical Chemistry with honors from The University of Kansas, USA. Since joining BMS R&D in 2000, he has held positions of increasing responsibility in design, development and technology transfer of small molecules as well as biologics drug products. He has broad experience in formulation development, process engineering, materials science, analytical sciences, CMC regulatory filing strategy and leading multi-disciplinary CMC teams. His research interests include solubilization, drug delivery, materials science, drug-excipient interactions, drug stability, biopharmaceutics modeling, formulation development and process scale-up. He has 29 manuscripts, 8 patents and numerous invited talks and presentations. He also served on the 2010-2015 USP Excipients Expert Committee.

Affiliations and expertise

Executive Director, Drug Product Science & Technology, Bristol-Myers Squibb, New Brunswick, NJ, USA

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Developing Solid Oral Dosage Forms

Pharmaceutical Theory and Practice

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Yihong Qiu

Yisheng Chen

Geoff G.Z. Zhang

Lawrence Yu

Rao V. Mantri