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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Guides,
ADME/DMPK,
IND Enabling Studies/Preclinical Development
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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Guides,
Toxicology & Safety
Fasiglifam (TAK-875) is a GPR40 agonist which was developed for the treatment of type 2 diabetes. However, during Phase III clinical trials, it was withdrawn due to adverse liver effects.
In this poster, we focus on:
- deciphering the mechanism of hepatotoxicity of fasiglifam (TAK-875)
- understanding the impact of plasma protein binding and mitochondrial effects by fasiglifam using the Seahorse flux analyser platform
Read our poster to learn more about our research!
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Tags:
Posters,
Toxicology & Safety
The skin is the largest organ in the human body. It contains enzymes capable of drug metabolism.
In this presentation, we focus on:
- the physiology of the skin and an overview of skin enzymology
- the role of skin metabolism in absorption, efficacy, homeostasis, drug delivery and toxicity
- adverse reactions in the skin including the mechanism behind skin sensitisation
- in vitro methods for investigating skin metabolism
View the presentation to learn more!
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Presentations,
ADME/DMPK
Pharmacokinetic/pharmacodynamic (PK/PD) modelling plays an important role in drug development, especially in the case of antibiotics where the data generated is used for dose prediction up to Phase 2 clinical trials. This enables efficient study designs and identification of optimal dosing regimens that may suppress drug resistance.
In this poster, we focus on:
- mathematical modelling of in vivo and in vitro data to generate a rational design with reduced animal requirements in order to determine the pharmacodynamic driver and magnitude of antibiotic efficacy
- optimisation of the clinical dose regimen in Phase 2 clinical trials
Read our poster to learn more about our research!
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Tags:
Posters,
In vivo Pharmacology
