Population PK modelling as an alternative route to bioequivalence

Autor: Parmesh Gajjar, Jake Dickinson, Harri Dickinson, Linette Ruston, Hitesh B Mistry, Claire Patterson, Paul A Dickinson

Publikováno v: British Journal of Pharmacy, Vol 7, Iss 2 (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.

Externí odkaz: https://doaj.org/article/c0cbd0c6968b4276bb1ea30e5eb83198

The spindle assembly checkpoint and speciation

Autor: Robert C. Jackson, Hitesh B. Mistry

Publikováno v: PeerJ, Vol 8, p e9073 (2020)

A mechanism is proposed by which speciation may occur without the need to postulate geographical isolation of the diverging populations. Closely related species that occupy overlapping or adjacent ecological niches often have an almost identical geno

Externí odkaz: https://doaj.org/article/02b97afbf10349f780579c59bfac78ae

Pretreatment Lymphocyte Count Predicts Benefit From Concurrent Chemotherapy With Radiotherapy in Oropharyngeal Cancer

Autor: James M. Price, Hitesh B. Mistry, Guy Betts, Eleanor J. Cheadle, Lynne Dixon, Kate Garcez, Tim Illidge, Zsuzsanna Iyizoba-Ebozue, Lip Wai Lee, Andrew McPartlin, Robin J.D. Prestwich, Savvas Papageorgiou, Dylan J. Pritchard, Andrew Sykes, Catharine M. West, David J. Thomson

Publikováno v: Journal of Clinical Oncology. 40:2203-2212

PURPOSE There is a need to refine the selection of patients with oropharyngeal squamous cell carcinoma (OPSCC) for treatment de-escalation. We investigated whether pretreatment absolute lymphocyte count (ALC) predicted overall survival (OS) benefit f

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b1fcf6507099dccee6ad30bab1390c42
https://doi.org/10.1200/jco.21.01991

Determining bioequivalence possibilities of long acting injectables through population PK modelling

Autor: Parmesh Gajjar, Jake Dickinson, Harri Dickinson, Linette Ruston, Hitesh B. Mistry, Claire Patterson, Paul A. Dickinson

Publikováno v: Gajjar, P, Dickinson, J, Dickinson, H, Ruston, L, Mistry, H B, Patterson, C & Dickinson, P A 2022, ' Determining bioequivalence possibilities of long acting injectables through population PK modelling ', European Journal of Pharmaceutical Sciences, vol. 179, pp. 106296 . https://doi.org/10.1016/j.ejps.2022.106296

Long acting injectables (LAI) products are a popular intervention for treating a number of chronic conditions,with their long drug release reducing the administration frequency and thus improving patient adherence.The extended release, however, can p

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::215bae9bda3603ee7c158672ee47c0ab
https://doi.org/10.1016/j.ejps.2022.106296

Association between radiotherapy protocol variations and outcome in the CONVERT trial

Autor: Romaana Mir, Nicki Groom, Hitesh B. Mistry, Elena Wilson, Corinne Faivre-Finn

Publikováno v: Mir, R, Groom, N, Mistry, H B, Wilson, E & Faivre-Finn, C 2023, ' Association between radiotherapy protocol variations and outcome in the CONVERT trial ', Clinical and translational radiation oncology, vol. 39, pp. 100560 . https://doi.org/10.1016/j.ctro.2022.100560

BackgroundRadiotherapy quality assurance (QA) is integral to radiotherapy delivery. Here we report comprehensive contouring, dosimetry, and treatment delivery QA, describe protocol compliance, and detail the impact of protocol variations on acute gra

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ce822198c9c929a6dec6b5d8dfe1c580
https://pubmed.ncbi.nlm.nih.gov/36578530