What test systems are needed for my in-house DMPK studies?
You need options; each in vitro assay is used to answer a specific question within a drug’s metabolism and pharmacokinetics, and while some studies require whole cell systems such as hepatocytes, others may be specific to drug metabolizing enzymes and call instead for subcellular fractions like S9 or microsomes to amplify activity.
Our designated Test Systems Specialists & Production team have been perfecting techniques for more than 25 years to isolate hepatocytes and prepare high-quality cell fractions that maintain high activity so you can collect accurate, consistent data predicting your drug’s effects in vivo. In vitro assays comprise a critical component of preclinical drug safety and in the vitro models you select must be reliable to produce data upon which crucial go/no-go decisions are made.
Regulatory authorities’ requirements and recommendations can sometimes present investigators with multiple alternatives for appropriate test systems and methodology, so we’ve put our heads together to compile a simple guide to the different test systems available.
|Applications||In Vitro Test Systems|
|Plateable Cryopreserved Hepatocytes||Pooled Cryopreserved Hepatocytes||Individual
|Kupffer Cells||Pooled/S9/Cystosol / Homogenate||Pooled Microsomes||Individual Micosomes/S9/Cytosol||Recombinant Enzymes (rCYPS)||Lysosomes/Tritosomes|
|Uptake Transporter Assays||+++||+++||++||–||–||–||–||–||–|
|3D Hepatic Models||++||–||++||++||–||–||–||–||–|