Cargando…
Predictive Potential of BCS and Pharmacokinetic Parameters on Study Outcome: Analysis of 198 In Vivo Bioequivalence Studies
BACKGROUND AND OBJECTIVES: Understanding predictive potential of parameters to perform early bioequivalence (BE) risk assessment is crucial for good planning and risk mitigation during product development. The objective of the present study was to evaluate predictive potential of various biopharmace...
Autores principales: | Krajcar, Dejan, Grabnar, Iztok, Jereb, Rebeka, Legen, Igor, Opara, Jerneja |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10175306/ https://www.ncbi.nlm.nih.gov/pubmed/36872388 http://dx.doi.org/10.1007/s13318-023-00821-z |
Ejemplares similares
-
Predictive Potential of Acido-Basic Properties, Solubility and Food on Bioequivalence Study Outcome: Analysis of 128 Studies
por: Krajcar, Dejan, et al.
Publicado: (2023) -
Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report
por: Al Shoyaib, Abdullah, et al.
Publicado: (2023) -
An In Vivo Predictive Dissolution Methodology (iPD Methodology) with a BCS Class IIb Drug Can Predict the In Vivo Bioequivalence Results: Etoricoxib Products
por: Gonzalez-Alvarez, Isabel, et al.
Publicado: (2021) -
Evaluation of pharmacokinetics and safety with bioequivalence of Amlodipine in healthy Chinese volunteers: Bioequivalence Study Findings
por: Wang, Tongtong, et al.
Publicado: (2020) -
Natural Deep Eutectic Solvents (NADES) to Enhance Berberine Absorption: An In Vivo Pharmacokinetic Study
por: Sut, Stefania, et al.
Publicado: (2017)