Development/implementation of analytical methods
- Development of sensitive and specific assays for novel compounds or endogenous biochemicals with chromatography based procedures;
- Implementation of published analytical procedures;
- Validation of assay conditions in the following areas: linearity, specificity, precision, accuracy, and stability;
- Preparation of analytical method standard operating procedure documents.
Analysis of clinical and pre-clinical samples
- Quantification of drug and metabolite(s) levels in biological samples;
- Quantification of endogenous biochemicals as surrogate markers of cancer risk or intervention effect;
- Incorporation of quality control standards during the quantitative analysis of clinical and pre-clinical samples for quality assurance;
- Identification of unknown metabolites of agents in development;
- Submission of analytical data in spreadsheet or hard-copy formats to study investigators;
- Archiving and back-up storage of analytical data (chromatograms, standard curves, and assay procedures) for future reference or regulatory audits.
Pharmacokinetic study design and data analysis
- Design sample collection schemes based on the review/analysis of literature information or computer simulations;
- Determine the quantitative relationships between drug exposure, surrogate markers, and drug effects through pharmacokinetic-pharmacodynamic modeling;
- Summarize and interpret pharmacokinetic data and prepare pharmacokinetic reports for the investigators;
- Provide training and consultation to investigators regarding incorporation of pharmacokinetic endpoints into clinical and pre-clinical studies.
Suggested procedures for sample preparation
Sample preparation procedures are study-dependent. It is important to consult with Chemistry Personnel before sample collection begins to ensure proper procedures so that sample stability or solvent incompatibility problems are avoided or minimized.
Turn around time
Turn around time will vary based on the services required and the current volume of usage. Qualitative analyses can typically be done same day or next day depending on instrumental availability. Assay setup typically take 1 to 4 weeks.