Calvert Holdings

Calvert Holdings provides vision, resources, and business leadership for all of the companies it develops and acquires. Life sciences are a core competency, but not all our business endeavors are within that field. Click the links to explore our companies, or contact us for more information.
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Pharmacokinetics – Toxicokinetics – ADME

Calvert Laboratories’ pharmacokinetic, toxicokinetic, and ADME group is dedicated to providing quality PK/TK/ADME services to the pharmaceutical and biotechnology industries in a timely and cost-effective manner. We offer a full range of services which allow our clients to predict the absorption, distribution, metabolism, and excretion of their compounds.

Pharmacokinetics / Toxicokinetics

During the Discovery Phase in drug development, Calvert can assist your initial PK screening of lead drug candidates or evaluation of different dosing formulations. We develop cost-effective study designs and protocols customized to your particular needs. Pharmacokinetic studies are conducted routinely in rodents (mice and rats), rabbits, dogs, non-human primates, and swine using many routes of administration. Calvert maintains a colony of male and female non-naïve dogs and a colony of male and female non-naïve Cynomolgus monkeys. These animals are available for rapid turnaround studies at costs well below studies using naïve animals. Analyses of toxicokinetic data derived from those dose levels used in animal toxicity studies are provided in supplemental reports.

In Vivo, Ex Vivo, and In Vitro ADME

In addition to providing clients with traditional pharmacokinetic and toxicokinetic data analysis, interpretation, and report generation, Calvert conducts the following preclinical studies: single and multiple dose PK profiling; bioavailability and dose proportionality; mass balance; elimination and excretion; and tissue distribution. Our facility is licensed for 16 radioisotopes, including 14C, 3H, 125I, 131I, 33P, and 35S. Ex vivo services include blood cell partitioning and plasma protein binding studies. Plasma protein is determined using ultrafiltration and equilibrium dialysis techniques. In vitro ADME services include drug-metabolizing enzyme inhibition and induction, reaction phenotyping, metabolic stability, metabolite characterization and identification, liver toxicity, and transporter studies.

Bioanalytical

The PK/ADME group at Calvert is responsible for providing analytical support for our GLP-compliant toxicology, pharmacology and immunology studies. We can develop or transfer analytical methods for dosing formulation analysis which includes test article concentration, homogeneity, and formulated stability measurements. These analyses include use of UV-HPLC, UV/VIS spectrophotometry, and ELISA. Calvert offers a seamless process for your pharmacokinetic and toxicokinetic evaluations, one that begins with formulation and dosing, followed by sample collection and bioanalytical sample assay, and ending with data analysis and report generation. Quantitation of your compound in biological matrices such as blood, plasma, serum, urine, and tissues is usually accomplished using LC-MS/MS. All bioanalytical services are conducted according to the FDA Good Laboratory Practice (GLP) and other relevant regulatory guidelines.

Inquire today for more details about how Calvert can assist you with your PK/TK/ADME projects. We offer savings in time and costs that can expedite your development program.