A stability study measures the extent to which a product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding.
A study commonly includes: a stability indicating method assay, sterility (for sterile preparations), endotoxin (for most sterile preparations), pH, visual inspection, particulate matter, preservative effectiveness, preservative quantification, microbial limits (for non-sterile preparations), and the absence of specified organisms (for non-sterile preparations).
ARL Bio Pharma has extensive experience in analytical method development/validation for a variety of drug substances and products.
Our laboratory validates analytical methods based on ICH and USP guidelines and high-quality industry practices. Method parameters may include: precision, limit of detection, limit of quantitation, accuracy, linear range, specificity, robustness, system suitability, ruggedness and freeze-thaw.
A PK/PD study analyzes the rate and extent of absorption of the active ingredient or moiety and emphasizes the use of pharmacokinetic endpoints in an accessible biological matrix, such as blood, plasma, and/or serum, to indicate release of the drug substance from the drug product into the systemic circulation.
ARL Bio Pharma has extensive experience with chemical, manufacturing and controls testing for original and abbreviated new drug applications. This testing includes: identification tests, quantitative tests for impurities content, limit tests for the control of impurities, performance tests such as dissolution, and quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in the drug product.
ARL Bio Pharma can provide characterization of a biological product (includes determination of physiochemical properties, biological activity, immunochemical properties, purity and impurities) by appropriate techniques as necessary to allow relevant specifications to be established.