Results 41 to 50 of about 826 (178)
Pharmaceutical Research, 2023 AbstractPurposeTo construct a detailed mechanistic and physiologically based biopharmaceutics model capable of predicting 1) device-formulation-tissue interaction during the injection process and 2) binding, degradation, local distribution, diffusion, and drug absorption, following subcutaneous injection.
Xavier J. H. Pepin +2 more
openaire +2 more sources
Development of Biopredictive Dissolution Method for Extended-Release Desvenlafaxine Tablets
Pharmaceutics, 2023 This study aimed to develop a biopredictive dissolution method for desvenlafaxine ER tablets using design of experiments (DoE) and physiologically based biopharmaceutics modeling (PBBM) to address the challenge of developing generic drug products by ...
Gustavo Vaiano Carapeto +3 more
doaj +1 more source
Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. Case example: Naproxen [PDF]
, 2022 Art. 105170Background Physiologically-based population pharmacokinetic modeling (popPBPK) coupled with in vitro biopharmaceutics tools such as biorelevant dissolution testing can serve as a powerful tool to establish virtual bioequivalence and set ...
Fotaki, N. +4 more
core +2 more sources
Accelerating Subcutaneous Drug Development: A Mechanistic Absorption Model for the Open Systems Pharmacology Framework. [PDF]
CPT Pharmacometrics Syst PharmacolABSTRACT This study describes the implementation of a mechanistic subcutaneous (SC) injection model for the Open Systems Pharmacology platform. As the SC route of administration is gaining increased popularity, there is a growing need for tools to predict, analyze, and understand the SC absorption process and the mechanisms involved.
Pellowe M, Dubbelboer I, Sjögren E.
europepmc +2 more sources
Is a Clinical Trial With a Non-Bioequivalent Batch Necessary? The Critical Role of Intrasubject Variability in Olaparib Formulation Bridging by PBPK. [PDF]
Clin Pharmacol TherAlthough physiologically based pharmacokinetic (PBPK) modeling is increasingly being used to support oral drug formulation bridging, the acceptance by regulatory agencies is low. One of the primary concerns is the absence of clinical pharmacokinetic (PK) data from a non‐bioequivalent (non‐BE) batch during model validation.
Dong J +6 more
europepmc +2 more sources
, 2022 SCR430, a sorafenib derivative, is an investigational drug exhibiting anti-tumor action. This study aimed to have a mechanistic understanding of SCR430’s time-dependent pharmacokinetics (TDPK) through an ex vivo study combined with an in vitro ...
Kim, Min-Chang +3 more
core +1 more source
Food and bile micelle binding of quaternary ammonium compounds
ADMET and DMPK, 2023 Background and Purpose: Physiologically-based biopharmaceutics modeling (PBBM) has been widely used to predict the oral absorption of drugs. However, the prediction of food effects on oral drug absorption is still challenging, especially for negative ...
Sumiji Takeru, Kiyohiko Sugano
doaj +1 more source
Pharmaceutics, 2020 In the present work, we explored if Coca-Cola® had a beneficial impact on the systemic outcome of the weakly basic drug loratadine (Wal-itin®, immediate-release formulation, 10 mg, generic drug product).
Bart Hens +5 more
doaj +1 more source
, 2022 S.135-145The objective of the present study was to develop a physiologically based biopharmaceutics (PBBM) approach to predict the bioequivalence of dosage forms containing poorly soluble drugs.
Dressman, J.B., Kambayashi, A.
core +1 more source
, 2022 The objective of the study was to predict pharmacokinetic (PK) and pharmacodynamic (PD) parameters of matrix based modified release (MR) drug product of vildagliptin.
Ahmed Madny, Muzaffaruddin +4 more
core +1 more source