Scientific Reports
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Industry news
The US Food and Drug Administration (FDA) on 11 May made available an International Council for Harmonisation’s (ICH) guideline on post-approval changes for drug products and issued four other final ICH documents and one draft guidance. The ICH Q12 guideline aims to facilitate the management of post-approval chemistry, manufacturing and controls (CMC) changes for new and marketed […]
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CacoReady in the Literature
In European Pharmaceutical Review’s latest podcast episode, supported by Lonza, Assistant Editor Hannah Balfour discusses all things bioavailability with Dr Deanna Mudie, a Principal Scientist in Research and Development at Lonza’s site in Bend, Oregon, US. “For oral drugs, bioavailability is the fraction of the administered dose that actually reaches your systemic circulation unchanged,” explains Deanna, continuing that it must […]
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PreadyPort BCRP and MDR1 in the Literature
A study that employed in vitro models of transporter-overexpressing MDCKII cells and Caco-2 monolayers along with an in vivo pharmacokinetic assay in male Wistar rats to (i) verify the inhibitory effect of rilpivirine to MDR1, BCRP, MRP2, OCT1, OCT2, or MATE1 transporters and to (ii) investigate possible ABC and/or SLC transporter-mediated interactions between rilpivirine and abacavir or lamivudine. More Info […]