GLP In Vivo ADME & PK Studies

GLP In Vivo ADME & PK Studies - Creative Biolabs

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.


Our services are for research use only. We do not provide services directly to individuals.

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CONTACT US

USA
45-1 Ramsey Road, Shirley, NY 11967, USA
Tel: 1-631-381-2994
Fax: 1-631-207-8356
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