Results 31 to 40 of about 781 (182)

Integrated biopharmaceutical approach in pharmaceutical development and drug characterization: General concept and application [PDF]

Hemijska Industrija, 2020
The importance of biopharmaceutical considerations in pharmaceutical development and drug characterization has been well recognized both by pharmaceutical industry and regulatory authorities as a tool to establish predictive relationships ...
Cvijić Sandra V., Ibrić Svetlana R., Parojčić Jelena V.   +2 more
doaj   +1 more source

Accelerating Generic Long-Acting Antiretrovirals for Global HIV Treatment: Workshop Findings and a Roadmap to Access. [PDF]

Clin Pharmacol Ther
The global HIV response aims for widespread availability of affordable, quality‐assured long‐acting antiretroviral (LA ARV) drugs to achieve sustained epidemic control, particularly in low‐ and middle‐income countries. This report summarizes key discussion points, findings, and outcomes from an international workshop on generic LA ARVs, held in ...
Arshad U, Gaayeb L, Pertinez H, Rajoli RKR, Watkins M, Nimbolkar P, Perazzolo S, Pagi B, Wensing A, Khoo S, Boffito M, Holm R, Panos Z, Mahaka I, Venter F, Kottiri B, Crawford KW, Ho RJY, Clayden P, Domanico P, Struble K, Owen A, Flexner C.   +22 more
europepmc   +2 more sources

BCS-based biowaivers: Extension to paediatrics

European Journal of Pharmaceutical Sciences, 2020
A BCS-based biowaiver allows extrapolation of drug product bioequivalence (when applicable) based on the BCS class of the drug and in vitro dissolution testing. Drug permeability and solubility considerations for adult BCS might not apply directly to paediatric subpopulations and bridging of adult and paediatric formulations should be undertaken with ...
J. Martir, T. Flanagan, J. Mann, N. Fotaki   +3 more
openaire   +3 more sources

Biowaiver for Immediate and Modified Release Dosage forms Scientific summary of the CSPS workshop

Journal of Pharmacy & Pharmaceutical Sciences, 2020
A joint Canadian Society for Pharmaceutical Sciences and Health Canada workshop entitled “Biowaiver for Immediate and Modified Release Dosage forms” was held in Ottawa, November 19th 2015. A summary of all presentations is included.
Raimar Loebenberg
doaj   +1 more source

In Vivo Predictive Dissolution (IPD) for Carbamazepine Formulations: Additional Evidence Regarding a Biopredictive Dissolution Medium

Pharmaceutics, 2020
The aim of the present study was to bring additional evidence regarding a biopredictive dissolution medium containing 1% sodium lauryl sulphate (SLS) to predict the in vivo behavior of carbamazepine (CBZ) products.
Marival Bermejo, Jessica Meulman, Marcelo Gomes Davanço, Patricia de Oliveira Carvalho, Isabel Gonzalez-Alvarez, Daniel Rossi Campos   +5 more
doaj   +1 more source

Application in silico Modeling Simulation in Bioequivalence Studies: A Review

Journal of Food and Pharmaceutical Sciences, 2023
Bioequivalence testing aims to ensure that the therapeutic performance of the drug is consistent and reproducible when it is administrated. Modeling and simulation in silico methods are currently performed to conduct virtual bioequivalence studies ...
Sekar Ayu Pawestri
doaj   +1 more source

Optimization of solubility studies performed in the context of BCS biowaiver monographs

, 2022
Die vorliegende Dissertation stellt eine Methode zur Löslichkeitsbestimmung vor, die für die Anwendung im Rahmen von BCS-Biowaiver Monografien entwickelt wurde.
Plöger, Gerlinde Friederike
core   +1 more source

Current issues in biowaivers and biosimilars [PDF]

Expert Review of Clinical Pharmacology, 2012
International Conference on Biowaivers and BiosimilarsSan Antonio, TX, USA, 10–12 September 2012An International Conference on Biowaivers and Biosimilars was held in San Antonio (TX, USA) on September 10–12, 2012. The conference was organized by OMICS Group Inc.
openaire   +2 more sources

Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development

Clinical and Translational Science, Volume 16, Issue 12, Page 2756-2764, December 2023., 2023
Abstract Immediate‐release (IR) solid oral drug products constitute a significant portion of approved drug products and products under development. Bioequivalence (BE) assessment for these oral products is important for establishing therapeutic equivalence for generic products to their respective comparator products. In December 2022, the International
Joseph Kotsybar, Susan Hakeem, Lei Zhang, Wenlei Jiang   +3 more
wiley   +1 more source

Evaluation of Differences in Dosage Form Performance of Generics Using BCS-Based Biowaiver Specifications and Biopharmaceutical Modeling

, 2022
S.2437-2453Drug products containing the antibiotics amoxicillin (500 mg as trihydrate) or doxycycline (200 mg as hyclate or monohydrate) with varying qualitative excipient composition were obtained from the German market and their biopharmaceutical ...
Hofsäss, M.A., Dressman, J.
core   +1 more source