PHARMout Laboratories is a GLP-compliant CRO specializing in quantitative LC/MS/MS method development, validation, and analysis.
We provide bioanalytical support for discovery, preclinical, and clinical stage studies. These include ADME, PK, toxicology and clinical trial studies.
Bioanalytical Support for Clinical Studies
Support of small, large, and/or multiple clinical studies. Sample receipt, sample tracking, and sample suppository services. Method development, validation, and sample analysis performed in full compliance with regulatory guidelines. Complete quality assurance auditing at each stage of study. Bioanalytical report for regulatory submission with compliance statements. Interim results reporting and expedited bioanalysis available.
Single or multiple analyte method development.
Complete method validation or method transfer
Compliance with FDA and white paper guidances
Quality control sample and stock solution stability confirmation
Incurred sample reproducibility
Established batch acceptance criteria
Whole blood stability for sample collection intergrity
Toxicology (GLP) Services
Bioanalytical analysis for toxicokinetics for non-clincal laboratory studies
Method development, validation, and sample analysis performed in full compliance with regulatory guidelines
Sample storage and solution stability confirmation. Incurred sample reproducibility evaluation
Complete and thorough quality assurance audits throughout study
GLP compliant bioanalytical report and documentation
Sample storage stability, solution stability and incurred sample reproducibility
Expedited Discovery Services
Dependable and expedient bioanalytical support for research and development studies such as ADME and pharmacokinetic (PK) studies
Method development and analysis in all types of biological matrices
Results provided on the next business day on request
Data interpretation and elucidation
Support for small or on-going studies
PHARMout Laboratories, Inc. has extensive experience at applying bioanalytical techniques for the analysis biomarkers. These include renin activity, fatty acid analysis, aldosterone, angiotensin II, GLP-1, T3 T4, and others. Analysis of biomarkers can be performed in a regulated setting or for research and development.
PHARMout Laboratories, Inc. specializes in the analysis of tissue samples for drugs and biomarkers. Our automated tissue homogenization provides optimal accuracy and precision for tissue extractions together with rapid sample processing.
PHARMout Laboratories, Inc. has expanded our ligand binding capabilities which include multiple biomarkers.
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