Results 51 to 60 of about 781 (182)

Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions [PDF]

Pharmaceutical Research, 2002
The current BSC guidance issued by the FDA allows for biowaivers based on conservative criteria. Possible new criteria and class boundaries are proposed for additional biowaivers based on the underlying physiology of the gastrointestinal tract. The proposed changes in new class boundaries for solubility and permeability are as follows: 1.
Polli, James E., Yu, Lawrence X., Mehta, Mehul U., Amidon, Gordon L., Zhao, Hong, Lesko, Lawrence J., Chen, Mei-Ling, Lee, Vincent H. L., Shah, Vinod P., Conner, Dale P., Hussain, Ajaz S.   +10 more
openaire   +3 more sources

Biowaiver Based on the Biopharmaceutical Classification System: Regulatory Basis and Limits of Scientific Interpretation (Review)

Регуляторные исследования и экспертиза лекарственных средств
INRODUCTION. Biowaiver procedure based on the biopharmaceutics classification system (BCS) is widely used in regulatory practice when assessing the bioequivalence of generic medicinal products (GMPs).
N. J. Dahma, E. T. Zhilyakova, D. A. Fadeeva, M. J. Dahma, R. Alrouhayyah, K. A. Nikitin   +5 more
doaj   +1 more source

In Silico Prediction of Plasma Concentrations of Fluconazole Capsules with Different Dissolution Profiles and Bioequivalence Study Using Population Simulation

Pharmaceutics, 2019
A biowaiver is accepted by the Brazilian Health Surveillance Agency (ANVISA) for immediate-release solid oral products containing Biopharmaceutics Classification System (BCS) class I drugs showing rapid drug dissolution.
Marcelo Dutra Duque, Daniela Amaral Silva, Michele Georges Issa, Valentina Porta, Raimar Löbenberg, Humberto Gomes Ferraz   +5 more
doaj   +1 more source

Physiologically based absorption modeling to predict the bioequivalence of two apixaban formulations. [PDF]

Clin Transl Sci
Abstract The equivalence of absorption rates and extents between generic drugs and their reference formulations is crucial for ensuring therapeutic comparability. Bioequivalence (BE) studies are widely utilized and play a pivotal role in substantiating the approval and promotional efforts for generic drugs.
Luo T, Wang L, Ruan Z, Lou H, Yang D, Wang Z, Zhao P, Jiang B.   +7 more
europepmc   +2 more sources

BCS-based biowaivers : risks and opportunities

, 2016
Bei peroral eingenommenen Arzneimitteln wird das Plasmakonzentrations-Zeit-Profil des aktiven Stoffes im Allgemeinen als Maß für die Wirksamkeit und Sicherheit des Arzneimittels angesehen. Bei Veränderungen an bestehenden Arzneimitteln oder der Entwicklung eines Generikums kann durch Bioäquivalenzstudien an gesunden Probanden untersucht werden, ob das ...
Kubbinga, ME
openaire   +5 more sources

Advances in Human Mass Balance Studies: An IQ Consortium Perspective on Current Practices and Emerging Trends

Clinical Pharmacology &Therapeutics, Volume 120, Issue 1, Page 43-54, July 2026.
Human radiolabeled mass balance studies are crucial for comprehensively characterizing the absorption, distribution, metabolism, and excretion (ADME) of investigational drugs, providing essential data for drug development, regulatory evaluation, and product labeling.
Jason Boer, Ellen Cannady, Filip Cuyckens, Ulrike Glaenzel, Camille Granvil, Felix Huth, Alexander D. James, Wenying Li, Céline Veau, Graeme Young, Qin Yue, Gregory S. Walker, Upendra A. Argikar, Jonathan N. Bauman, Cathy Cantalloube, Yu‐Luan Chen, Ping Kang, Patricia Moliner, Mette L. Pedersen, Isabel Piel, Simone Schadt, Hanno Schieferstein, Julia Suchomel, Shuai Wang, S. Cyrus Khojasteh   +24 more
wiley   +1 more source

Types of Biowaivers: A Discussion

International Journal of Drug Regulatory Affairs, 2019
The aim of the present review is to discuss the different types of biowaiver applications. Waiving of In vivo bioequivalence studies is known as biowaiver. Types of biowaiver applications include BCS based biowaiver, well established use application, also known as bibliographical application and Literature based submission.
openaire   +1 more source

Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 7, July 2026.
ABSTRACT Physiologically based pharmacokinetic (PBPK) modeling is a mechanistic cornerstone of model‐informed drug development (MIDD), providing evidence for regulatory decisions. PBPK models integrate physiological and pharmacological data and have been applied across a plethora of contexts of use, including assessing drug–drug interactions (DDIs ...
Marylore Chenel, Andre Dallmann, Ibrahim Ince, Michaela Meyer, Jan‐Frederik Schlender, Donato Teutonico, Erik Sjögren   +6 more
wiley   +1 more source

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Moxifloxacin Hydrochloride

, 2022
S.2654-2675In this monograph, literature data is reviewed to evaluate the feasibility of waiving in vivo bioequivalence testing and instead applying the Biopharmaceutics Classification System (BCS) based methods to the approval of immediate-release solid
Mehta, M., Groot, D.W., Parveen, T., Abrahamsson, B., Tajiri, T., Langguth, P., Dressman, J., Parr, A., Shah, V.P., Charoo, N.A., Polli, J.E., Abdallah, D.B., Cristofoletti, R.   +12 more
core   +1 more source

Scientific Opinion on waiving of the dog studies in the regulatory process of agrochemicals approval

EFSA Journal, Volume 24, Issue 7, July 2026.
Abstract Commission Regulation (EU) No. 283/2013 sets out the data requirements for pesticide active substances and includes short‐term oral toxicity testing in rodents (90‐day rat study) and non‐rodents (90‐day dog study) to support human health hazard assessment for pesticide active substances in the European Union (EU). However, the relevance of the
EFSA Panel on Plant Protection Products and their Residues (PPR), Tamara Coja, Pauline Adriaanse, Antonio Finizio, Maeva Giraudo, Thomas Kuhl, Emily McVey, Francesca Metruccio, Martin Paparella, Silvia Pieper, Eugenio Scanziani, Ivana Teodorovic, Paul Van der Brink, Martin Wilks, Antonio Hernandez‐Jerez, Olavi Pelkonen, Andrea Terron, Jochem Louisse, Martina Panzarea, Adriana Scattareggia Marchese, Judy Choi   +20 more
wiley   +1 more source