Medicilon's Preclinical Pharmacokinetic Study Services

2016-08-26

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Pharmacokinetics is the study of the way the body deals with the absorption, distribution, metabolism, and excretion of drugs under investigation expressed in mathematical terms. The effects and the duration of action of the drug are also taken into account.

Pharmacokinetic Study

With over 12 years of experience of operating a GLP and non-GLP compliant laboratory, Medicilon provides pharmacokinetic analysis and bioanalytical services with a dedicated team of specialists. We have carried out pharmacokinetic (PK), pharmacodynamics (PD) and toxicokinetic (TK) studies for all stages of drug development providing expertise and quality to our clients.

Medicilon’s Service:

Single dose toxicity test (rodent and non-rodent)
Repeated dose toxicity study (rodent and non-rodent)
Safety pharmacology test: telemetry and non-telemetry to monitor the electrocardiogram and respiration of dogs and monkeys, rats FOB
Genotoxicity tests
Reproductive toxicity test
Immunogenicity test
Toxicokinetic
Partial toxicity test

Pharmacokinetics:

Multi-dose Studies
Intermittent or continuous intravenous infusion
Bioequivalence and Bioavailability Testing
Stability studies
Absorption, Distribution, Metabolism, and Excretion (ADME):
Blood and plasma kinetics
Quantitative Tissue Distribution

Radioisotopes:

Common radioisotopes
Metabolite profiling and identification using HPLC radiochemical detector
Certificate of Analysis Development

Other Services:

High Pressure Liquid Chromatography (HPLC)
Mass Spectrophotometer for non-radiolabeled compounds

Steps Involved in Pharmacokinetics Study:

1. Absorption

Absorption is the process whereby a substance entering the body is assimilated by it. For proper pharmacokinetics study, it is necessary to know both the rate and the extent to which the active substance or therapeutic moiety are absorbed. They include substances intended to produce / not produce systematic effects.

2. Distribution

Distribution is the dispersion or dissemination of substances throughout the fluids and tissues of the body.

3. Metabolism

Metabolism is the process whereby a substance is irreversibly transformed into metabolites.

4. Excretion

Excretion is the elimination of the substance from the body. In rare cases, not all substances are eliminated; some drugs irreversibly accumulate in a tissue in the body.

Pharmacokinetics/toxicokinetics is “defined as the study of the rates of absorption, distribution, metabolism, and excretion [ADME] of toxic substances or substances under toxicological study”. Pharmacokinetics/toxicokinetics testing involves describing “the bioavailability of a substance and its kinetic and metabolic fate within the body”. Pharmacokinetics is also the term used to describe the assessment of ADME in the context of drug preclinical testing.

mouse model dog model