Preclinical Dose Formulation Analysis For GLP And Non-GLP Studies
Preclinical Dose Formulation Analysis For GLP And Non-GLP Studies
BioAgilytix provides dose formulation analysis in support of both GLP and non-GLP studies. Analysis of formulation samples to confirm test article concentration, homogeneity, and stability in formulations is an important part of any successful nonclinical study and is required by the United States Food and Drug Administration (US FDA) for formulations dosed in toxicology studies.
GLP formulation method validation
Nonclinical dose formulation analysis methods in support of regulated nonclinical studies must be appropriately validated across a range of parameters including recovery, accuracy, precision, specificity, selectivity, carryover, sensitivity, and stability. As experts in this field, BioAgilytix can quickly develop and validate LC/MS, HPLC/UV, or immunoassay methods for the analysis of drug content in liquid formulations. Our analytical approach to dose formulation method validation allows quick cross-validation of our assays for new formulation matrices, salt forms, and concentration ranges, thus saving time and money if the formulation requires changes.
During method validation, we will:
- Evaluate homogeneity and stability of the formulation across expected conditions during preparation, storage, dosing, and shipment
- Confirm solubility and stability prior to the start of toxicology studies
GLP-compliant “Certificate of Analysis (COA)” generation
BioAgilytix can also generate an audited Certificate of Analysis (COA) for Active Pharmaceutical Ingredients (API), metabolites, or internal standards. Analyses include HPLC purity, water content, mass confirmation, and other tests as applicable. Simply provide us with a reference standard and list of desired analyses or an old COA and we will issue an audited Certificate of Analysis for use in your GLP studies.
Equipment and software for dose formulation assays
As one of the largest bioanalytical LC/MS laboratories on the west coast of the United States, BioAgilytix has invested in state-of-the-art instrumentation to remain at the forefront of the industry. Learn more about our LC/MS instrumentation and 21 CFR Part 11 compliant software.
BioAgilytix’s preclinical bioanalytical services
Partnering with a CRO that has extensive bioanalytical experience in the nonclinical space is key to generating rapid, accurate results that can help streamline the transition from preclinical to clinical testing. In addition to dose formulation services, BioAgilytix offers comprehensive preclinical support from pharmacokinetics (PK) and drug metabolism assays to immunogenicity and biomarker testing. Learn more about our comprehensive preclinical services to support your program.