Samples: -Plasma or tissue samples generated for drug candidates in preclinical development, different phases of human clinical trials and GLP safety or toxicology studies.

Typical studies: -Definitive PK studies, formulation studies in preclinical species -Preclinical studies initiated by clinical observation or new indication -First in man studies such as Phase I single rising dose in healthy volunteers -Efficacy studies in man -Drug-drug interaction studies in man -Bioequivalent studies -Product enhancement studies (Phase IV-V) -GLP safety or toxicology studies

Method development and validation: Our method development strategy focuses on sensitivity, reproducibility, dynamic range, throughput and ruggedness. Stable isotope labeled internal standard is preferred. When it is not available, we perform extra tests to demonstrate that variation among subjects is minimum and acceptable. Preliminary method can be available in a couple of days for customer to review. Validation includes assay precision and accuracy, and all necessary stability evaluations. To best suit different requirements in drug development stages, ProTech Analytical has separate SOPs to address validation and sample analysis procedures for preclinical development, human studies and GLP studies. We ensure our SOPs follow the spirit of Good Laboratory Practices (GLP) and FDA guidance. We are open to follow customers' SOPs when a validated method is transferred or simply preferred by customers. A method development and validation report, or a cross validation report will be available to customers soon after the validation completes.

Sample analysis: Our SOPs specify how each analytical run should be performed. Confirmatory analysis of incurred sample is included. Run acceptance/rejection criteria are also cleared addressed. Some highlights are listed here. -Sufficient sets of QCs will be used to bracket unknown samples throughout each run. Each set of QCs includes lowest, 2nd lowest, mid and high concentrations. Diluted QCs will also be included if there is sample dilution. -Acceptance criteria: %CV <20% at LOQ and 15% at other levels, %accuracy within ±20% of nominal values at LOQ and ±15% at other levels -Any reassay due to ALQ, instrument malfunction, and errors in sample handling will be documented and samples will be reanalyzed. -Difference between initial and repeat analysis of incurred samples will be reported.

Data reporting: A Word bioanalytical report will be issued. The report contains a brief description of study design, QC summary from all runs, concentrations tables for all subjects on each treatment, incurred sample reanalysis table, representative chromatograms and an appendix of analytical protocol. Excel files of all tables will be available for quick view. Other raw data such as slope & correlation coefficient of each standard curve, precision of internal standard over entire run can be reported per your request.