Perspectives on Bioequivalence Pathways for Drug Product Approval

Across Dosage Form, Route of Administration and Geographical Jurisdictions
Erscheinungsjahr 2022
ISBN: 978-0-12-824141-7
Verlag: Elsevier Science

Buch, Englisch, 675 Seiten, Format (B × H): 191 mm x 235 mm

Perspectives on Bioequivalence Pathways for Drug Product Approval: Across Dosage Form, Route of Administration and Geographical Jurisdictions explains the role of alternative approaches to bioequivalence across various dosage forms, route of administration, and regulatory bodies with an ultimate aim of reducing clinical trial and bioequivalence study burdens. Sections focus on alternative bioequivalence approaches that can be fostered to minimize human testing, along with instigating new ideas and opening new avenues for the development of such approaches. It will be useful to pharmaceutical scientists working to produce affordable medicines to all as well as regulatory agencies, pharmaceutical companies, formulation scientists and clinical scientists.This book covers several administration routes and deals with biowaivers for dosage form, routes of administration and geographical jurisdiction. Divided into five sections, including oral drug products, ophthalmic drug products, topical and transdermal drug products, orally inhaled and nasal drug products, and complex injectables, this book includes multiple real-world case studies alongside theory and protocols.

Autoren/Hrsg.

Dubey, Vaibhav

Murthy, Narasimha

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Biomedizin, Medizinische Forschung, Klinische Studien
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie

Inhaltsverzeichnis

Section 1: Bioequivalence Pathways for Oral Drug Products across regulatory bodies with relevant case studies1. BCS based biowaiver approaches2. Safe Space based approaches3. Bioequivalence for drug products acting locally in GI tract

Section 2. Bioequivalence Pathways for Ophthalmic Drug products across regulatory bodies with relevant case studies4. Ophthalmic Gel Products5. Ophthalmic Emulsions6. Ophthalmic Suspensions

Section 3. Bioequivalence Pathways for Topical and Transdermal Drug products across regulatory bodies with relevant case studies7. Topical Gel Products8. Topical Cream Products9. Nail Drug Products and possible approaches10. Pediculicide hair tuft assay-based approaches11. Transdermal Drug products12. PBPK Approaches for Topical Drug Products

Section 4. Innovative Bioequivalence pathways for Topical drug products13. Dermal Microdialysis14. Dermal Open Flow Microdialysis15. Tape stripping-based approaches16. Antimicrobial kill rate studies for dermal products

Section 5. Bioequivalence Pathways for Orally Inhaled and Nasal Drug Products across regulatory bodies with relevant case studies17. Dry Powder Inhalers for Lung Diseases In vitro considerations for DPI18. BE Assessment for Inhalational Products19. Nasal Sprays20. Computational Fluid Dynamic based approaches for Absorption Prediction for Orally Inhaled and Nasal Products

Section 6. Bioequivalence Pathways for Complex injectables across regulatory bodies with relevant case studies21. Liposomal Drug products22. Injectable Microsphere and In Situ Implants23. Injectable Suspensions24. Injectable Emulsions

Über Autor(innen)

Dubey, Vaibhav
Dr. Dubey is Principal Scientist and Head 505b2 division at ALEOR Dermaceuticals, Hyderabad, INDIA. He also writes on Biowaiver approaches and submissions to various International Regulatory bodies including US FDA, MHRA and EMEA. He has worked in the development of various generic and innovative dosage forms mostly spinning in and around the Topical and Transdermal drug delivery domain. Previously he has served in companies like Sun Pharmaceuticals and Dr. Reddy's Laboratories, in INDIA. He has multiple patents to his credit in the field of nanotechnology and controlled drug delivery systems, alongwith contributing numerous publications in high repute journals, book chapters and poster presentations. Dr. Dubey has been awarded the prestigious Commonwealth fellowship and Federal Commission Scholarship during his PhD along with Indian Drug Manufacturer Association's Award, Prof CS Chouhan Award and University Gold Medals.

Murthy, Narasimha
Dr. S. Narasimha Murthy is the CSO of Topical Products Testing LLC, USA. He was former Professor of Pharmaceutics and Drug Delivery at the University of Mississippi School of Pharmacy, USA for over 15 years. Dr. Murthy is a pioneer in nanotechnology-based delivery systems, microneedles and microstructured delivery technologies of drug delivery and diagnosis, dermal and transdermal delivery of drugs and nose to brain delivery of therapeutics. His research programs are funded by NIH, FDA, and Pharmaceutical companies. He has published over 130 research papers and presented over 250 scientific posters in various national and international scientific meetings. He has authored two books and over fifteen book chapters. He is serving on the Editorial Board of several journals including AAPS Pharm Sci Tech, DDIP and J Pharm. Sci. He is a consultant to pharmaceutical and medical device companies in the USA, Israel, Italy, and India. Dr. Murthy has received several awards such as the New Investigator award and Cumberl and Researcher of the year from the University of Mississippi, Global Indus Technovator award from MIT, Endowed Chair for Research at the Ohio Northern University and he was inducted as the Fellow of the American Association of Pharmaceutical Scientists in 2017 and was bestowed with Distinguished Scientist award by American Association of Indian Pharmaceutical Scientists. Dr. Murthy is also a scientific philanthropist. He is the Founder Director of a non-profit research organization, Institute for Drug Delivery and Biomedical Research in Bangalore, India (www.IDBresearch.com).