The 2020 FDA guidance for in vitro DDI studies – new things to consider?
4 May 2020
In January 2020, the Final DDI Guidance for Industry was published. Similarly to the draft guidance, there are separate documents for in vitro and clinical drug interaction studies, which are to be used systemically to assess DDI potential. We’ll focus here on conducting in vitro DDI studies according the In Vitro Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance.Read more
A typical workflow in a preclinical pharmacokinetic experiment
25 February 2020
Despite a good part of ADME research in drug discovery and preclinical development can be performed using various in silico or in vitro systems, eventually it becomes necessary to evaluate also the pharmacokinetic (PK) profile in animals to elucidate in vivo DMPK properties of the drug candidates. This blog post summarises the components of a typical early PK study.Read more
Metabolites in safety testing (MIST) – How to ensure human metabolites are safe
27 January 2020
During drug development, also the safety of drug metabolites should be considered early enough to avoid massive delays in the progress of the project. There are few important things to keep in mind when investigating the safety of human metabolites, and Admescope’s Head of Safely Metabolism Dr Johanna Haglund will highlight these.Read more
Admescope's 2019 in a nutshell - an excellent year!
9 January 2020
I could say that the last two weeks of December are in many ways the best weeks of the year. The busiest time of the year is just over, it is couple of days slowing down towards the well-earned holidays and the atmosphere is just great. Yet then after the Christmas it is the best days to have a holiday, as phone is not ringing and no urgent emails are dropping to the inbox.Read more
Preclinical formulations for pharmacokinetic studies
25 November 2019
When new drug compounds are synthetized, typically as solid powders, at the preclinical stage many properties of the compounds are not known. Apart from biological activity, for example particle size and crystal structure play important roles in further research for the compound. In many in vitro studies, the compound is just fully solubilized in solvent eliminating the issues described above.Read more