Science Pool

Drug-Drug Interaction (DDI) Regulatory Guide

Posted by Evotec on Feb 16, 2021 10:13:56 AM

Our popular, easy-to-follow guide: 'DDI Regulatory Guidance' is now on its 3rd edition.

Read about:

  • an easy to follow summary and comparison of the latest DDI guidance from the FDA and the EMA
  • a focus on reaction phenotyping, cytochrome P450 inhibition, cytochrome P450 induction, drug transporter substrate studies and drug transporter inhibition
  • an overview of the regulatory methods and interpretation of data

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Tags: Guides, ADME/DMPK, IND Enabling Studies/Preclinical Development

Mechanisms of Drug-induced Toxicity Guide

Posted by Evotec on Feb 16, 2021 10:08:58 AM

Our popular, easy-to-follow guide: 'Mechanisms of Drug-induced Toxicity' is available to read online.

Read about:

  • an overview of the different mechanisms of toxicity including:
    • mitochondrial toxicity
    • reactive oxygen species (ROS) and oxidative stress
    • reactive metabolite formation
    • cell cycle mediated toxicity
    • apoptosis
    • genotoxic and non-genotoxic carcinogens
    • phospholipidosis
    • steatosis
    • cholestasis
    • cardiac ion channel effects and hypertrophy
  • an assessment of the current in vitro methods available for determining mechanistic toxicology 
  • key references and further reading related to the topic

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Tags: Guides, Toxicology & Safety