Zobrazeno 1 - 10
of 14
pro vyhledávání: '"Maxime Le Merdy"'
Publikováno v:
Pharmaceutics, Vol 16, Iss 7, p 914 (2024)
The development of generic ophthalmic drug products with complex formulations is challenging due to the complexity of the ocular system and a lack of sensitive testing to evaluate the interplay of its physiology with ophthalmic drugs. New methods are
Externí odkaz:
https://doaj.org/article/8095b13d760d4754a8fd2e1cacdf15b1
Autor:
Ming‐Liang Tan, Sajeev Chandran, Rebeka Jereb, Khondoker Alam, Robert Bies, Darby Kozak, Ross Walenga, Maxime Le Merdy, Andrew Babiskin
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 5, Pp 631-638 (2023)
Abstract For approval, a proposed generic drug product must demonstrate it is bioequivalent (BE) to the reference listed drug product. For locally acting drug products, conventional BE approaches may not be feasible because measurements in local tiss
Externí odkaz:
https://doaj.org/article/07ce5f1933ba47038ba1a9054cdc69a8
Autor:
Daniela Amaral Silva, Maxime Le Merdy, Khondoker Dedarul Alam, Yan Wang, Quanying Bao, Nilesh Malavia, Diane Burgess, Viera Lukacova
Publikováno v:
Pharmaceutics, Vol 16, Iss 4, p 552 (2024)
Long-acting injectable (LAI) formulations provide sustained drug release over an extended period ranging from weeks to several months to improve efficacy, safety, and compliance. Nevertheless, many challenges arise in the development and regulatory a
Externí odkaz:
https://doaj.org/article/d86a64d76c9b4e44936965b5c79a99cd
Publikováno v:
Pharmaceutics, Vol 16, Iss 1, p 96 (2024)
This study aimed to develop a physiologically based pharmacokinetic (PBPK) model that simulates metabolically cleared compounds’ pharmacokinetics (PK) in pregnant subjects and fetuses. This model accounts for the differences in tissue sizes, blood
Externí odkaz:
https://doaj.org/article/3790d3d8c50c4b73b51fe5b9445f98df
Autor:
Mark McAllister, Talia Flanagan, Susan Cole, Andreas Abend, Evangelos Kotzagiorgis, Jobst Limberg, Heather Mead, Victor Mangas-Sanjuan, Paul A. Dickinson, Andrea Moir, Xavier Pepin, Diansong Zhou, Christophe Tistaert, Aristides Dokoumetzidis, Om Anand, Maxime Le Merdy, David B. Turner, Brendan T. Griffin, Adam Darwich, Jennifer Dressman, Claire Mackie
Publikováno v:
Pharmaceutics, Vol 14, Iss 5, p 1010 (2022)
A webinar series that was organised by the Academy of Pharmaceutical Sciences Biopharmaceutics focus group in 2021 focused on the challenges of developing clinically relevant dissolution specifications (CRDSs) for oral drug products. Industrial scien
Externí odkaz:
https://doaj.org/article/ef6f2c994c1b4a04809bf2645feb40a0
Autor:
Maxime Le Merdy, Farah AlQaraghuli, Ming-Liang Tan, Ross Walenga, Andrew Babiskin, Liang Zhao, Viera Lukacova
Publikováno v:
Pharmaceutical Research. 40:431-447
Background The development of generic ophthalmic drug products is challenging due to the complexity of the ocular system, and a lack of sensitive testing to evaluate the interplay of physiology with ophthalmic formulations. While measurements of drug
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::94bf911cc1832b7cfaf07b46a518c637
https://doi.org/10.1007/s11095-022-03390-z
https://doi.org/10.1007/s11095-022-03390-z
Publikováno v:
Journal of Pharmacokinetics and Pharmacodynamics
A physiologically based model describing the dissolution, diffusion, and transfer of drug from the intra-articular (IA) space to the plasma, was developed for GastroPlus® v9.8. The model is subdivided into compartments representing the synovial flui
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c729c5b6913317fd70841476d14d277b
https://doi.org/10.1007/s10928-021-09781-w
https://doi.org/10.1007/s10928-021-09781-w
Publikováno v:
The AAPS Journal
The purpose of this study was to develop a physiologically based pharmacokinetic (PBPK) model predicting the pharmacokinetics (PK) of different compounds in pregnant subjects. This model considers the differences in tissue sizes, blood flow rates, en
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::be18d7d7ec7bc814717c939d364873ec
https://doi.org/10.1208/s12248-021-00603-y
https://doi.org/10.1208/s12248-021-00603-y
Publikováno v:
The AAPS journal. 22(2)
FDA’s Orange Book lists 17 currently marketed active pharmaceutical ingredients (API) formulated within ophthalmic suspensions in which a majority has 90% or more of the API undissolved. We used an ocular physiologically based pharmacokinetic (O-PB
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8624898a643504d9e4286ff0b267293f
https://pubmed.ncbi.nlm.nih.gov/31907674
https://pubmed.ncbi.nlm.nih.gov/31907674
Autor:
Sharron Stewart, Eleftheria Tsakalozou, Maxime Le Merdy, Murali K. Matta, Andrew Babiskin, Liang Zhao, Jianghong Fan, Suresh Narayanasamy, Lei Zhang, Ashok Chockalingam, Jessica Spires, Darby Kozak, Vikram Patel, Stephanie Choi, Lin Xu, Rodney Rouse, Robert Lionberger, Michael B. Bolger, Viera Lukacova
Publikováno v:
The AAPS journal. 21(4)
Developing mathematical models to predict changes in ocular bioavailability and pharmacokinetics due to differences in the physicochemical properties of complex topical ophthalmic suspension formulations is important in drug product development and r
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5d37467bd86299ed0bf4486feb5cec50
https://pubmed.ncbi.nlm.nih.gov/31111305
https://pubmed.ncbi.nlm.nih.gov/31111305