Successfully navigate FDA regulations for in vitro metabolism and drug transporters

1. A FULLY COMPLIANT,
DDI SOLUTION
Successfully navigate FDA regulations for
in vitro metabolism and drug transporters
▶ Is your drug a potential substrate, inhibitor
or inducer of drug-metabolizing enzymes or
transporters?
▶ Would your drug benefit from physiologically
based pharmacokinetic (PBPK) and
pharmacokinetic/pharmacodynamics (PK/PD)
modeling solutions for clinical DDIs?
▶ Are you prepared to complete your studies prior
to first-in-human (FIH) studies?
Leverage our experience with large and small molecules,
utilizing radiolabeled and non-radiolabeled services to meet
regulatory guidelines.
Integrated Solution, Linking Preclinical to Clinical
A Fully Regulatory Compliant End-to-End Solution
FDA recommends PBPK and
PK/PD studies initiate before
FIH studies:
▶ Identify major routes of
elimination
▶ Assess enzyme and transporter
contribution to your drug’s
disposition
▶ Determine how your drug may
affect enzymes and transporters
▶ Evaluate DDI potential of
metabolites
Trust Covance with Your Next In Vitro Metabolism and Drug Transporter Study
We invest in our organization through harmonization efforts, so you can have the same experience in our
metabolism studies across the globe.
covance.com/metabolism
In Vitro
Data
In Vitro
Modeling
Comprehensively Designed
In Vivo Clinical DDI Studies+ =
Substrate
Determination
Enzyme
Inhibition
Enzyme
Induction
Transporter
▶ CYP450
▶ UGT
▶ Non-P450
▶ Km
and Vmax
as needed
▶ IC50 and Ki
▶ Time
dependent
inhibition
▶ Ki
and kinact
as
needed
▶ Cryopreserved
human
hepatocytes
▶ mRNA and
activity
endpoint
▶ All systems
required
by various
authorities
▶ Substrate
determination
▶ Inhibition
   
Covance Inc., headquartered in Princeton, NJ, USA is the drug development business of Laboratory
Corporation of America Holdings (LabCorp). COVANCE is a registered trademark and the
marketing name for Covance Inc. and its subsidiaries around the world.
The Americas + 1.888.COVANCE (+1.888.268.2623) + 1.609.452.4440
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