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

Abstract GS3-10: Study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in combination with fulvestrant in patients with advanced hormone receptor positive HER2 negative breast cancer (HR+BC)

Autor: Charles Coombes, Sasha J Howell, Matthew G Krebs, Simon Lord, Laura M Kenny, Ash Bahl, Glen Clack, Edward Ainscow, Paul A Dickinson, Raluca Fostea, Janine Mansi, Carlo Palmieri, Gianflippo Bertelli, Rinath Jeselsohn, Zahi Mitri, William J Gradishar, Sagar Sardesai, Joyce O'Shaughnessy, Patrick Ward, Pavani Chalasani, Manfred Lehnert, Simak Ali, Stuart McIntosh

Publikováno v: Cancer Research. 82:GS3-10

Background: CDK7 inhibition is a promising therapeutic strategy in cancer; acting as a regulator of the cell cycle, transcription and endocrine receptor signalling [1]. Patients with HR+BC post CDK4/6 inhibitor treatment have a poor prognosis; median

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::ab14751d8b635b13c2effbd7bdbdb5c6
https://doi.org/10.1158/1538-7445.sabcs21-gs3-10

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

EXPERIENTIAL EDUCATION AND LANGUAGE IMPROVEMENT THROUGH P2P INTERNATIONAL PROJECTS

Autor: Paul Gordon Dickinson

Publikováno v: European Journal of Alternative Education Studies. 6

In order to meet the needs of employers and to make students more employable Laurea University, Finland has developed an “experiential” educational model through project-based learning in English based around real business projects linking theory

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::0261fa6146ecf2633f04f6f2de1506b4
https://doi.org/10.46827/ejae.v6i1.3602

Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products

Autor: Arzu Selen, Anette Müllertz, Filippos Kesisoglou, Rodney J. Y. Ho, Jack A. Cook, Paul A. Dickinson, Talia Flanagan

Publikováno v: The AAPS Journal. 22

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::7fa62d2e93ebea04aba421b410a86023
https://doi.org/10.1208/s12248-020-00470-z