State of the art and uses for the biopharmaceutics drug disposition classification system (BDDCS): new additions, revisions, and citation references
Abstract The Biopharmaceutics Drug Disposition Classification system (BDDCS) is a four-
class approach based on water solubility and extent of metabolism/permeability rate. Based …
class approach based on water solubility and extent of metabolism/permeability rate. Based …
Parameterization of physiologically based biopharmaceutics models: workshop summary report
X Pepin, S Arora, L Borges, M Cano-Vega… - Molecular …, 2024 - ACS Publications
This Article shares the proceedings from the August 29th, 2023 (day 1) workshop
“Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product …
“Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product …
Role of physiologically based biopharmaceutics modeling (PBBM) in fed bioequivalence study waivers: regulatory outlook, case studies and future perspectives
S Kollipara, FS Martins, M Sanghavi… - Journal of …, 2024 - Elsevier
Over the past few decades, physiologically based biopharmaceutics modeling (PBBM) has
demonstrated its utility in both new drug and generic product development. Applications of …
demonstrated its utility in both new drug and generic product development. Applications of …
Current state and challenges of physiologically based biopharmaceutics modeling (PBBM) in oral drug product development
D Wu, M Li - Pharmaceutical Research, 2023 - Springer
Physiologically based biopharmaceutics modeling (PBBM) emphasizes the integration of
physicochemical properties of drug substance and formulation characteristics with system …
physicochemical properties of drug substance and formulation characteristics with system …
Development of In Vitro Dissolution Testing Methods to Simulate Fed Conditions for Immediate Release Solid Oral Dosage Forms
TR Lex, JD Rodriguez, L Zhang, W Jiang, Z Gao - The AAPS Journal, 2022 - Springer
In vitro dissolution testing is widely used to mimic and predict in vivo performance of oral
drug products in the gastrointestinal (GI) tract. This literature review assesses the current in …
drug products in the gastrointestinal (GI) tract. This literature review assesses the current in …
[HTML][HTML] The global bioequivalence harmonisation initiative (GBHI): report of the fifth international EUFEPS/AAPS conference
M Mehta, B Schug, HH Blume, G Beuerle… - European Journal of …, 2023 - Elsevier
The series of conferences of the Global Bioequivalence Harmonisation Initiative (GBHI) was
started in 2015 by the European Federation for Pharmaceutical Sciences (EUFEPS). All …
started in 2015 by the European Federation for Pharmaceutical Sciences (EUFEPS). All …
Assessment of food effects during clinical development
Food-drug interactions frequently hamper oral drug development due to various
physicochemical, physiological and formulation-dependent mechanisms. This has …
physicochemical, physiological and formulation-dependent mechanisms. This has …
[HTML][HTML] Key Factors for Improving Predictive Accuracy and Avoiding Overparameterization of the PBPK Absorption Model in Food Effect Studies of Weakly Basic …
M Zhang, S Zhang, L Wang, Z Zhang, Q Hu, D Liu - Pharmaceutics, 2024 - mdpi.com
Background/Objectives: Physiologically based pharmacokinetic (PBPK) absorption models
are instrumental for assessing drug absorption prior to clinical food effect studies, though …
are instrumental for assessing drug absorption prior to clinical food effect studies, though …
Physiologically based biopharmaceutics model for selumetinib food effect investigation and capsule dissolution safe space–part I: adults
XJH Pepin, M Hammarberg, A Mattinson… - Pharmaceutical …, 2023 - Springer
Objective A physiologically based biopharmaceutics model (PBBM) was developed to
mechanistically investigate the effect of formulation and food on selumetinib …
mechanistically investigate the effect of formulation and food on selumetinib …
Using mechanistic modeling approaches to support bioequivalence assessments for oral products
F Wu, Y Mousa, R Jereb, H Batchelor, S Chakraborty… - The AAPS Journal, 2024 - Springer
This report summarizes the proceedings for Day 1 Session 3 of the 2-day public workshop
entitled “Best Practices for Utilizing Modeling Approaches to Support Generic Product …
entitled “Best Practices for Utilizing Modeling Approaches to Support Generic Product …