Pre-clinical and Clinical Sample Analysis

///Pre-clinical and Clinical Sample Analysis
Pre-clinical and Clinical Sample Analysis 2018-05-15T14:06:34+00:00

Pre-clinical and Clinical Sample Analysis

Our dedicated and experienced scientists partner with you to obtain quality bioanalytical data to guide decision making and help regulatory submission.  Our services give you the depth and width of both non-GLP and LC/MS GLP Bioanalysis.

Supported Studies:

Screening rodent, rabbit, dog pharmacokinetic studies

Pharmacokinetic/pharmacodynamic (PK/PD) and efficacy studies

Non-clinical Toxicokinectic (TK) studies

Clinical pharmacokinetic and bioavailability studies

Drug/Drug interaction studies

Bioequivalence studies

Typical samples:

Discovery, nonclinical and clinical samples of various cellular sample, bio-fluids, dried blood spots and tissues. Click here for more Sample matrices

Sample matrices:

Plasma Brain Kidney Tumor Bile
Whole blood Heart Intestine Vitreous fluid Cerebrospinal fluid
Urine Liver Colon Aqueous humor Bronchial lavage fluid
Feces Lung Bone Marrow Instestinal fluid Cell lysate/culture

Equipment:

·     Mass Spetrometer- AB SCIEX API4000, API4000Qtrap, API5000, Thermo Q Exactive

·     HPLC: Shimadzu Nexera UHPLC, Thermo Ultimate 3000 UHPLC, Agilent 1200 HPLC

·     Tissue processing: Polytron, TissueLyser, Precellys

·     Liquid handling: Sciclone 3000, Zephyr Sampling Station, Agilent Bravo Liquid Handling                System, HTC PAL autosamplers

GLP sample analysis:

Our facility and information technology system are meticulously designed and well maintained for GLP studies.  The critical and non-critical equipment such as HPLC, mass spectrometer, sample storage systems, balances and pipettes are qualified and calibrated. Our staff are fully trained to work in compliance with the current FDA and OECD guideline and our comprehensive standard operation procedures.  Our dedicated Quality Assurance Unit (QAU) ensures uncompromised quality system including SOPs, protocols, methods, practices, records, reports, trainings, and facilities.