The impact of the EMA change in definition of “dose” on the BCS dose–solubility ratio: a review of the biowaiver monographs
A Sediq, M Kubbinga, P Langguth… - Journal of Pharmaceutical …, 2014 - Elsevier
Abstract The Biopharmaceutics Classification System (BCS) defines the solubility
characteristics of an active pharmaceutical substance based on its dose–solubility ratio: for …
characteristics of an active pharmaceutical substance based on its dose–solubility ratio: for …
Scientific considerations concerning the EMA change in the definition of “dose” of the BCS-based biowaiver guideline and implications for bioequivalence
C Daousani, P Macheras - International Journal of Pharmaceutics, 2015 - Elsevier
This work discusses the scientific aspects of the definition of dose as the 'highest single oral
IR dose'recommended for administration in the SmPC (summary of product characteristics) …
IR dose'recommended for administration in the SmPC (summary of product characteristics) …
Acceptability and characteristics of 124 human bioequivalence studies with active substances classified according to the Biopharmaceutic Classification System
E Ramirez, O Laosa, P Guerra, B Duque… - British journal of …, 2010 - Wiley Online Library
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• In USA and Europe the classical way
to guarantee equivalence between different formulations is the bioequivalence (BE) study …
to guarantee equivalence between different formulations is the bioequivalence (BE) study …
Global testing of a consensus solubility assessment to enhance robustness of the WHO biopharmaceutical classification system
V Gigante, GM Pauletti, S Kopp, M Xu… - ADMET and …, 2021 - hrcak.srce.hr
Sažetak The WHO Biopharmaceutical Classification System (BCS) is a practical tool to
identify active pharmaceutical ingredients (APIs) that scientifically qualify for a waiver of in …
identify active pharmaceutical ingredients (APIs) that scientifically qualify for a waiver of in …
New guidelines for the assessment of bioavailability and bioequivalence
H Blume, B Schug, J Tautz, K Erb - Bundesgesundheitsblatt …, 2005 - Springer
Bioavailability and bioequivalence studies are essential in the clinical development of
medicinal products and the optimization of pharmaceutical forms. Bioavailability means the …
medicinal products and the optimization of pharmaceutical forms. Bioavailability means the …
Elucidating the Role of Dose in the Biopharmaceutics Classification of Drugs: The Concepts of Critical Dose, Effective In Vivo Solubility, and Dose-Dependent BCS
G Charkoftaki, A Dokoumetzidis, G Valsami… - Pharmaceutical …, 2012 - Springer
Purpose To develop a dose dependent version of BCS and identify a critical dose after
which the amount absorbed is independent from the dose. Methods We utilized a …
which the amount absorbed is independent from the dose. Methods We utilized a …
Bioequivalence requirements in the European Union: critical discussion
A García-Arieta, J Gordon - The AAPS journal, 2012 - Springer
The aim of the present paper is to summarize the revised European Union (EU) Guideline
on the Investigation of Bioequivalence and to discuss critically with respect to previous …
on the Investigation of Bioequivalence and to discuss critically with respect to previous …
Modern bioavailability, bioequivalence and biopharmaceutics classification system. New scientific approaches to international regulatory standards
R Löbenberg, GL Amidon - European journal of pharmaceutics and …, 2000 - Elsevier
In the last decade, the regulatory bioequivalence (BE) requirements of drug products have
undergone major changes. The introduction of the biopharmaceutics drug classification …
undergone major changes. The introduction of the biopharmaceutics drug classification …
Evolution of choice of solubility and dissolution media after two decades of biopharmaceutical classification system
N Bou-Chacra, KJC Melo, IAC Morales, ES Stippler… - The AAPS journal, 2017 - Springer
The introduction of the biopharmaceutics drug classification system (Biopharmaceutics
Classification System (BCS)), in 1995, provided a simple way to describe the …
Classification System (BCS)), in 1995, provided a simple way to describe the …
Very rapid dissolution is not needed to guarantee bioequivalence for biopharmaceutics classification system (BCS) I drugs
H Kortejärvi, R Shawahna, A Koski… - Journal of …, 2010 - Wiley Online Library
Currently, the EMEA, FDA, and WHO as regulatory authorities accept rapidly dissolving (>
85% dissolved in 30 min) biopharmaceutics classification system (BCS) I drug products for …
85% dissolved in 30 min) biopharmaceutics classification system (BCS) I drug products for …