Results 31 to 40 of about 1,942 (154)
Bioequivalence study of ipratropium bromide inhalation aerosol using PBPK modelling
Frontiers in Medicine, 2023 AimsSystemic pharmacokinetic (PK) studies can reflect the overall exposure of orally inhaled drug Products (OIDPs) in the blood after inhalation into the lung and can be used to evaluate the bioequivalence of test and reference products.
Jisheng Zhang +7 more
doaj +1 more source
CPT: Pharmacometrics & Systems Pharmacology, 2023 On November 30, 2021, the US Food and Drug administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a virtual public workshop titled “Establishing the Suitability of Model‐Integrated Evidence (MIE) to Demonstrate Bioequivalence ...
Yuqing Gong +17 more
doaj +1 more source
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
Clinical and Translational Science, 2023 In vivo pharmacokinetic simulations and virtual bioequivalence (BE) evaluation of cilostazol have not yet been described for humans. Here, we successfully developed a physiologically based absorption model to simulate plasma concentrations of cilostazol.
Lu Wang +8 more
doaj +1 more source
Virtual Trial Comparisons and Bioequivalence Assessment: From Data-Based to Probabilistic Assessment
, 2023 The recent emergence of virtual comparative trials, in particular for virtual bioequivalence (VBE) assessment, implies a formalization of their analyses. In recent VBE assessments, pharmacokinetic models informed with in vitro data and verified with small clinical trials data were used to simulate otherwise unfeasibly large trials. Simulated VBE trials
Brochot, Céline, Bois, Frederic Yves
openaire +1 more source
Population PK modelling as an alternative route to bioequivalence
British Journal of Pharmacy, 2022 Demonstrating bioequivalence (BE) is important for the development of lower-cost generic products, and also for approving post-submission manufacturing changes. However, for many complex parenteral products, BE demonstration can be very challenging.
Parmesh Gajjar +6 more
doaj +1 more source
Bioequivalence study of two brands of phenytoin sodium 100mg formulations in healthy adult male rabbits [PDF]
, 2013 The objective of the study was to compare the bioavailability of a single oral 100 mg dose of two brands of phenytoin sodium formulations available in the Nepalese market.
Banskota, Suhrid +6 more
core +1 more source
CPT: Pharmacometrics & Systems Pharmacology, 2023 On September 30 and October 1, 2021, the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics cosponsored a live virtual workshop titled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence ...
Andrew Babiskin +12 more
doaj +1 more source
Real-time assessment of critical quality attributes of a continuous granulation process [PDF]
, 2013 There exists the intention to shift pharmaceutical manufacturing of solid dosage forms from traditional batch production towards continuous production. The currently applied conventional quality control systems, based on sampling and time-consuming off ...
Córdoba Díaz, Damián +6 more
core +1 more source
Frontiers in Pharmacology, 2022 Biowaiver based on the biopharmaceutics classification system (BCS) has been widely used in the global market for the approval of new generic drug products to avoid unnecessary in vivo bioequivalence (BE) studies.
Xian Zhang +7 more
doaj +1 more source