GLP In Vivo ADME & PK Studies

Thorough characterization and in-depth study of PK, as well as absorption, distribution,

metabolism, and excretion (ADME) properties, are critical in order to support vaccine
discovery and development processes for the production of safer and more effective
vaccines. Creative Biolabs offers our customers a series of GLP in vivo ADME and PK
Studies.

ADME is an abbreviation in vaccinology for "absorption, distribution, metabolism, and

excretion," and describes the disposition of a vaccine within the organism. The four
criteria all influence the vaccine levels and kinetics of vaccine exposure to the tissues and
hence influence the performance and pharmacological activity of the vaccine. The
vaccine enters the body and usually must be brought into the bloodstream. Routes of
administration are an important consideration. Some factors that affect vaccine
distribution include regional blood flow rates, molecular size, polarity, and binding to
serum proteins to form complexes. In the case of natural barriers such as the blood-brain
barrier, the distribution can be a serious problem. As soon as the compound enters the
body, it begins to decompose. When metabolism occurs, the original (parent) compound
is converted to a new compound called a metabolite. Above all, ADME studies are a
crucial part of the comprehensive safety evaluation of a new vaccine.

Our Services
 The ADME studies are designed to support discovery, lead candidate selection,
preclinical testing, and clinical programs. Creative Biolabs provides ADME and PK in
vivo research for our clients and various routes of administration including oral, dermal,
intravenous, infusion, inhalation, intrathecal and intraperitoneal as well as other delivery
options according to your needs. Using our rapid pharmacokinetic approach, candidates
can be rapidly screened, followed by pre-clinical ADME and clinical pharmacokinetics to
obtain a complete ADME data package to support global regulatory submissions.
Available services:

 Dosing frequency
 Routes of administration
 Interspecies comparisons
 Various surgical models
 Pharmacokinetic / Toxicokinetic (PK/TK)
 Quantitative tissue distribution

 Micro-autoradiography
 Metabolite isolation and characterization
 Radioactivity sample analysis
 Bioavailability evaluation
 Bioequivalence studies

Creative Biolabs offers custom ADME studies of various species. Our experienced
scientists frequently conduct PK/TK and tissue distribution studies to determine clearance
rates and pathways after systemic exposure, tissue half-life, metabolite profiles, and
potential sites of toxicity. We use custom labeled test material and manage it in a variety
of ways to provide comprehensive fully electronic data collection and evaluation that
meets GLP requirements. We can arrange and manage tailored radiosynthesis according
to your need and can repurify and dilute radioactively labeled test material as required.
Various isotopes are available upon request.

As one of the most highly respected vaccine testing laboratories in the world, Creative
Biolabs is committed to help you through the assessment stages of development with our
excellent preclinical GLP in vivo ADME & PK studies. We promise rapid experimental
timelines and competitive prices.