Time-Proof Perspectives on Bioequivalence

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Carla Sofia Pinheiro Vitorino -Assistant Professor, Pharmaceutics, Nanotechnology, Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal
João José Martins Simões de Sousa – Associate Professor, Pharmaceutical Technology, Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal
António José Leitão das Neves Almeida – Professor, Pharmaceutical Technology, Research Institute for Medicines, Faculty of Pharmacy, University of Lisboa, Lisboa, Portugal
Margarida Isabel Silva Coutinho de Miranda Rodrigues, PhD – Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal (ORCID iD: 0000-0002-4142-8455)

Series: Pharmacology – Research, Safety Testing and Regulation
BISAC: MED072000
DOI: https://doi.org/10.52305/WKNM2164

The aim of this book is to provide insights on the methods currently available to holistically support the bioequivalence assessment. The Bioequivalence assessment has become the cornerstone of generic drug approval worldwide, enabling the introduction of generic equivalents of innovative drugs through appropriate assessment, as required by the various regulatory authorities. Considerations for the planning and design of bioequivalence studies are constantly evolving to create harmonized standards that address the complexity of the technologies that support drug development today. This has led to discussions between regulators and industry, and academy stakeholders seeking updated practices.

In this context, this book intends to address these issues cross-functionally in a balanced description between conventional and complex pharmaceutical dosage forms to highlight key recent advances. Special attention is given to the harmonization of biopharmaceutical classification systems based on biowaivers, common shortcomings in generic drug development, bioequivalence statistics, and alternative in vitro and in silico bioequivalence approaches as emerging issues and enhanced science-based trends in the field.

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Table of Contents

Foreword

Preface

Chapter 1. Standard Dosage Forms: Oral Immediate Release Dosage Forms
Marta Filipe Simões and Sérgio Simões
Pharmaceutical Technology, Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal
Bluepharma – Indústria Farmacêutica, S.A., Coimbra, Portugal

Chapter 2. The Bioequivalence of Modified Release Oral Dosage Forms
Maria de Fatima Pina1 and Maria Malamatari2,3
1Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, Coimbra, Portugal
2School of Health Sciences, Department of Pharmacy, Frederick University, Nicosia, Cyprus
3Institute for Globally Distributed Open Research and Education (IGDORE)

Chapter 3. Fixed-Dose Combination Drug Products
Daniela M. Zagalo1,2, João Sousa1,3 and Sérgio Simões1,2
1Faculty of Pharmacy, University of Coimbra, Azinhaga de Santa Comba, Coimbra, Portugal
2Bluepharma – Indústria Farmacêutica, São Martinho do Bispo, Coimbra, Portugal
3Coimbra Chemistry Centre, Department of Chemistry, University of Coimbra, Rua Larga, Coimbra, Portugal

Chapter 4. Topical Dosage Forms: Bioequivalence at a Glance
Ana M. Martins, Andreia Ascenso, Ana Costa, Sandra Simoes, Helena M. Ribeiro and Joana Marto
Research Institute for Medicines (iMed.ULisboa), Universidade de Lisboa, Lisbon, Portugal

Chapter 5. Common Deficiencies in Generic Drug Product Development
Marc B. Brown1, Charles R. Evans1, Matthew J. Traynor1 and Richard H. Guy2
1MedPharm Ltd, Surrey Research Park, Guildford, Surrey, United Kingdom
2Department of Life Sciences, University of Bath, Claverton Down, Bath, United Kingdom

Chapter 6. Topical Bioequivalence Design Studies: An Update
Margarida Miranda1,2,3,4, Alberto A. C. C. Pais2 and Carla Vitorino2,4
1CiiEM – Egas Moniz Center for Interdisciplinary Research (CiiEM), Egas Moniz School of Health & Science, Caparica, Almada, Portugal
2Coimbra Chemistry Center, Institute of Molecular Sciences – IMS, Department of Chemistry, University of Coimbra, Coimbra, Portugal
3Laboratórios Basi, Mortágua, Portugal
4Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal

Chapter 7. An Overview of Bioequivalence Requirements for Generic Transdermal Products
Dina Ameen1,2, Nirali Dholaria1,2, Anika Haq1,2, Benjamin Goodyear1,2, Hana Mohd1,2, Parinbhai Shah1,2, Amitkumar Virani1,2, Julia Zhang1,2, Vinam Puri1,2 and Bozena Michniak-Kohn1,2
1Department of Pharmaceutics, Ernest Mario School of Pharmacy, Rutgers-The State University of New Jersey, Piscataway, New Jersey, USA
2Center for Dermal Research, Rutgers-The State University of New Jersey, Piscataway, New Jersey, USA

Chapter 8. Injectable Products’ Bioequivalence Assessment
Danina Krajišnik1, Sanela Savić2, Tanja Ilić1 and Snežana Savić1
1Department of Pharmaceutical Technology and Cosmetology, University of Belgrade-Faculty of Pharmacy, Belgrade, Serbia
2Research and Development Sector, DCP Hemigal, Leskovac, Serbia

Chapter 9. Nanoparticle-Based Products: An Example of Complex Dosage Forms
Juan M. Irache
Department of Chemistry and Pharmaceutical Technology, University of Navarra, Pamplona, Spain

Chapter 10. Biopharmaceutical Classification System Based-Biowaiver Harmonization
David P. Elder
David P. Elder Consultancy Ltd. Hertford, UK

Chapter 11. Commonly Used Methods for Dissolution Profile Comparison
Zhengguo Xu1,2, Matilde Merino-Sanjuan1,3, Alfredo García-Arieta4 and Victor Mangas-Sanjuán1,3
1Department of Pharmacy and Pharmaceutical Technology and Parasitology, University of Valencia, Valencia, Spain
2Pharmacokinetics Department, Towa Pharmaceutical Europe, S. L., Barcelona, Spain
3Interuniversity Research Institute for Molecular Recognition and Technological Development, Polytechnic University of Valencia-University of Valencia, Valencia, Spain
4División de Farmacología y Evaluación Clínica, Departamento de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain

Chapter 12. Spotlight on Bioequivalence Modeling and Simulations
Paulo Paixão
Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal

Chapter 13. Physiologically-Based Pharmacokinetic Modeling to Support the Determination of Drug Product Bioequivalence
Mariana Neves1, Margarida Miranda2,3,4, João Sousa1,3 and Carla Vitorino1,3
1Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal
2Egas Moniz Center for Interdisciplinary Research (CiiEM), Egas Moniz School of Health & Science, Caparica, Almada, Portugal
3Coimbra Chemistry Center, Department of Chemistry, University of Coimbra, Coimbra, Portugal
4Laboratórios Basi, Mortágua, Portugal

Index

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