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PK Profile /PK Parameter

Pharmalegacy has expertise in designing, performing, and interpreting the results of pharmacokinetic studies in all species. Study design and selection of the appropriate model to be used are often customized to meet the project needs. PK studies typically involve the use of fully conscious animals that have been appropriately catheterized for drug administration and sample collection. Special surgical preparations such as catheterizations of portal vein and bile duct, can also be performed, if required. Pharmacokinetic study samples mighT include blood, bile, or other matrices, as well as tissues or tumor specimens that have special bioanalytical requirements. Analysis of pharmacokinetic samples is typically performed using LC/MS/MS.

Pharmalegacy performs pharmacokinetic studies (all routes of administration including IP, IV, PO, SC etc.) in multiple species (rodent, dog, rabbit, guinea pig, monkey) for projects at the discovery screening stage (rapid turnaround to meet high-through-put needs), IND-enabling studies, as well as toxicokinetic studies. The data are interpreted by our Pharmacokinetics staff using industry-standard WinNonlin software.


In Vivo Pharmacokinetic Study

In Vivo Dosing

w  Intravenous (bolus/infusion)

w  Oral, subcutaneous, intramuscular, intradermal, plus other route

w  Intra-duodenal, intra-portal

Species

w  Rodent

w  Canine

w  Non-human primate

w  Rabbit

w  Guinea pig

Outputs

w  Sample concentrations

w  PK parameters (WinNonLin)

Services

w  Bioavailability

w  Single and multiple dose PK

w  Dose ranging and proportionality

w  Cassette PK for compound screening

w  Drug distribution in tissues

w  PK study for formulation/form development

w  Exploratory non-GLP TK studies

w  PK/PD study in animal disease models

w  PK study for IND filing

w  ADA assays in non-human primate

Instrument

w  LC-MS/MS (API4000)

w  HPLC-UV (Agilent 1200)

w  Micro-plate reader


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