ICH Guideline M3 recommends that information on absorption, distribution,
metabolism and excretion (ADME) in animals should be available to compare human
and animal metabolic pathways by the time that Phase I (human pharmacology)
studies have been completed. It follows therefore that extensive ADME data should
be available prior to initiation of Phase II. Huntingdon Life Sciences offer
a full service for ADME and in vitro metabolism studies including:
Data interpretation and analysis by a specialised group of qualified pharmacokineticists.
- Fully validated QWBA systems and specialised QWBA group
- Conventional quantitative tissue distribution (QTD) techniques for radioisotopes
unsuitable for QWBA
- Microautoradiography capability
- Placental transfer studies in pregnant animals (rodent and rabbit)
- Plasma protein binding (ultrafiltration, equilibrium dialysis and ultracentrifugation
used routinely); including binding to specific proteins, determination of
binding sites and drug-drug interactions on binding
Bile-duct studies (rodent and non-rodent) for biliary excretion and enterohepatic
circulation studies.
- Metabolite-profiling with on-line or off-line radiodetection
- Structural characterisation and identification of metabolites
- Specialised group of mass spectroscopists with specific expertise in metabolite
identification
- Dedicated instrument with LC and GC input -including Q-TOF Micro MS system
with UPLC
- Experience in isolation and purification of radiolabelled metabolites for
NMR analysis and established links with NMR facilities for structural confirmation
by this technique
- Comparative metabolism (isolated cells, precision-cut tissue slices, subcellular
fractions)
- CYP and UGT identification (reaction phenotyping)
- CYP inhibition
- CYP induction
- Drug-drug interactions
- Metabolite generation and identification
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