Utility of Physiologically Based Biopharmaceutics Modeling (PBBM) in Regulatory Perspective: Application to Supersede f2, Enabling Biowaivers & Creation of Dissolution Safe Space

Autor: Bhattiprolu, Adithya Karthik, Kollipara, Sivacharan, Ahmed, Tausif, Boddu, Rajkumar, Chachad, Siddharth

Publikováno v: In Journal of Pharmaceutical Sciences December 2022 111(12):3397-3410

BCS-based biowaivers: Extension to paediatrics

Autor: Martir, J., Flanagan, T., Mann, J., Fotaki, N.

Publikováno v: In European Journal of Pharmaceutical Sciences 1 December 2020 155

Drug Permeability - Best Practices for Biopharmaceutics Classification System (BCS)-Based Biowaivers: A workshop Summary Report.

Autor: Mehta, M.¹ (AUTHOR) mehul.mehta@fda.hhs.gov, Polli, J.E.² (AUTHOR), Seo, P.¹ (AUTHOR), Bhoopathy, S.³ (AUTHOR), Berginc, K.⁴ (AUTHOR), Kristan, K.⁴ (AUTHOR), Cook, J.⁵ (AUTHOR), Dressman, J.B.⁶ (AUTHOR), Mandula, H.¹ (AUTHOR), Munshi, U.¹ (AUTHOR), Shanker, R.⁵ (AUTHOR), Volpe, D.A.¹ (AUTHOR), Gordon, J.⁷ (AUTHOR), Veerasingham, S.⁸ (AUTHOR), Welink, J.⁹ (AUTHOR), Almeida, S.¹⁰ (AUTHOR), Gonzalez, P.¹¹ (AUTHOR), Painter, D.⁸ (AUTHOR), Tsang, Y.C.¹² (AUTHOR), Vaidyanathan, J.¹ (AUTHOR)

Publikováno v: Journal of Pharmaceutical Sciences. Jul2023, Vol. 112 Issue 7, p1749-1762. 14p.

Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications

Autor: Ines Lenić, Kevin Blake, Alfredo Garcia‐Arieta, Henrike Potthast, Jan Welink

Publikováno v: Clinical and Translational Science, Vol 12, Iss 5, Pp 490-496 (2019)

The waiver of the in vivo demonstration of bioequivalence (biowaiver) is an established tool in drug development and regulatory assessment. This study reviews the use of different biowaiver approaches in centralized applications for marketing authori

Externí odkaz: https://doaj.org/article/0bb60b2ea71e4f289177e8a2d1c105b3

Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities

Autor: Matthias Shona Roost, Henrike Potthast, Chantal Walther, Alfredo García-Arieta, Ivana Abalos, Eduardo Agostinho Freitas Fernandes, Gustavo Mendes Lima Santos, Zulema Rodríguez Martínez, Andrew Tam, Clare Rodrigues, Diego Alejandro Gutierrez Triana, Erwin Guzmán Aurela, Nayive Rodríguez Rodríguez, Sang Aeh Park, Jayoung Kim, Rami Kariv, Milly Divinsky, Ben Jones, Ryosuke Kuribayashi, Aya Myoenzono, Miho Kasuga, Joy van Oudtshoorn, Jo-Feng Chi, Wen-Yi Hung, Li-Feng Hsu, Christopher Crane, Tony Jarman, April Braddy

Publikováno v: Journal of Pharmacy & Pharmaceutical Sciences, Vol 24 (2021)

This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release so

Externí odkaz: https://doaj.org/article/f47a65a70d0c4d7a8b8f9d4102479b05