Pharmacokinetics studies assess the body’s effect on the drug. Typically, this includes measurement of absorption, metabolism, excretion, and distribution, as well as systemic exposure.
Customized pharmacokinetics and ADME programs
Preclinical GPS customizes PK and ADME plans for each drug and program. This customization takes into account the following:
- Modality of your drug (small molecule, antibody, peptide, oligonucleotide, or other)
- Appropriate species selection
- Stage of drug development
- Clinical route and dosing regimen
Preclinical GPS routinely runs PK and ADME studies for small and large molecules. Typical studies for small molecules include in vitro assessments for stability, metabolite identification, interaction with cytochrome P450s, interactions with drug transporters, and in vivo PK, and in vivo PK/PD studies. Large molecules are assessed for stability and PK/PD relationships. Special studies are also conducted depending on the molecule and program.
Preclinical GPS also supports development programs by managing method development and validation, as well as toxicokinetic support for GLP studies.
Preclinical GPS has conducted over 800 preclinical studies. Annually, we typically manage over 40 preclinical studies to support 2 to 4 INDs.
How we help
We manage the outsourcing process for these studies using only reputable and experienced laboratories. The outsourcing process includes designing studies, generating requests for proposals, negotiating contracts, implementing studies, monitoring studies, reviewing data and preparing reports. Outsourced studies are supported by our proprietary project management processes to ensure on-time, on budget delivery.
We also author pharmacokinetic and ADME sections of regulatory documents to support IBs, INDs, NDA, CTA, and BLAs.