Services


PHARMout Laboratories is a GLP-compliant CRO specializing in quantitative LC/MS/MS method development, validation, and analysis.


We provide DMPK screening, efficacy/toxicity assessment, PK/PD modeling, proteomics, and analytical/bioanalytical services


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

                 



                Analytical Services


                •HPLC method development/validation of analytical/stability-indicating assays

                •Forced degradation test and drug degradant/impurity analysis
                •Drug dissolution test
                •Develop and validate cleaning validation methods
                •Material testing according to USP or customer’s specifications
                •Characterization of polymers using size exclusion chromatography


                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

                 



                Biomarkers

                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.


                Proteomics


                Characterization of post-translational modifications of proteins using high-resolution MS.


                 



                Tissue Homogenization


                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.

                 



                Ligand Binding


                 PHARMout Laboratories, Inc. has expanded our ligand binding capabilities which include multiple biomarkers.

                 



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