Human AME
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Human AME

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As an comprehensive biomedical preclinical R&D services CRO, based on advanced technology and expert scientists, BOC Sciences is committed to providing human AME services to facilitate your drug discovery process.

Introduction

Human absorption, metabolism, and excretion (human AME) studies, human radiolabel-AME studies, evaluate the pharmacokinetics, mass balance, excretion pathways, and metabolic pathways of the parent drug to ensure that the metabolite profile was comparable to that observed in preclinical ADME studies and to identify any disproportionate or unique human metabolites.

More than ever, new drug discovery relies on AME studies and toxicology testing. Conduct human AME studies (especially if there are any potentially toxic metabolites or metabolites unique to humans compared to animals, and/or if you need to establish early information about major metabolites and excretion patterns to plan future study designs), to evaluate radiolabeled drugs in humans with the help of BOC Sciences.

Why Human AME is Needed

  • Determine the major metabolic pathways, the major metabolic sites, and the proportion of metabolites in each major metabolic pathway to total clearance of the subject drug in humans.
  • Elucidate the enzymes associated with metabolite production, the effects of potential inhibition and induction, and the impact of possible genetic polymorphisms on metabolism.
  • Clarify relevant enzyme kinetic parameters when performing experimental design for metabolite interaction studies.

Human AME

Why Conduct Human AME Studies As Early As Possible?

  • Plan clinical DDI studies, renal/hepatic impaired elderly, pediatric
  • Plan future PK and phase I/Ill study dose levels
  • Gender differences
  • Polymorphically expressed enzymes, CYP450, Transporters (e.g. PM, EM subgroups)
  • Assist with possible BCS class 1 biowaiver
  • Plan carcinogenicity study - match metabolites
  • Future drug design - protect IP

Our Human AME Studies

As a world leading provider of human AME studies, we have extensive experience, we have the scientific expertise and operational knowledge to design and deliver human AME programs, helping our customers to better understand the nature and quantity of drug metabolites formed in the human body with the clear information they need.

Objectives
  • To obtain substance balance data and excretion pathways of the tested drugs in the human body
  • To elucidate the main biotransformation pathways and elimination mechanisms of the test drug in humans
  • Confirm the correct selection of animal species for toxicity studies
  • To elucidate whether the major metabolic products in vivo have an impact on efficacy and toxicology
Key Human AME Test
  • Plasma isolation
  • Bioavailability
  • Conventional and nanotracer administration
  • Mass balance
  • Metabolite identification
  • Metabolite analysis
  • Pharmacokinetics

Our Advantages

  • World class science teams
  • Expertise in reviewing clinical and non-clinical data and designing the human investigations
  • Effective study delivery
  • Scientific analysis and interpretation of clinical metabolism data

Results of Human AME Study

  • Metabolite ratios made into tables
  • High resolution MS/MS spectra
  • Spectral analysis
  • Proposed biotransformation pathway

Quotation and Ordering

As with all of our live services, we make sure to keep in touch during the study. If you have any special needs or questions about our services, please feel free to contact us to support our experienced experts. We look forward to working with you in the future.