Regulatory | Cyprotex

Archive for the ‘Regulatory’ Category

What’s New in the January 2020 US FDA In Vitro Drug-Drug Interactions (DDI) Guidance?

In January 2020, the US FDA gave its stamp of approval by finalising its 2017 draft regulatory […]

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In vitro transporter studies

Species Differences in Hepatic Uptake – A Focus on the Oatp Transporter

The most important OATP family member expressed in the human liver is OATP1B1, responsible for hepatic uptake […]

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In silico Modelling

Pharmacokinetic/Pharmacodynamic (PK/PD) Modelling of Antibiotic Efficacy

PK/PD modelling is an important aspect of dose prediction of antibiotics for both preclinical and clinical development […]

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In vitro transporter studies

Deciphering the Mechanism behind Clinical Drug-Drug Interactions (DDIs) between Simvastatin Acid and Telithromycin using In Vitro Studies

Drug-drug interactions (DDIs) can often be a complex mix of multiple mechanisms – therefore understanding the impact […]

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In vitro transporter studies

In vitro Regulatory Drug-Drug Interaction Studies – Getting the Design Right Matters

The guidelines for the US FDA, EMA and Japanese PMDA are constantly evolving as our understanding of […]

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