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Leachables are compounds that migrate from the medical device into a patient. There are two possible routes of entry for leachables: direct patient tissue contact or by first migrating into a drug product which then carries the leachable into the patient. Leachables present a potential risk to the patient both from the toxicity of the leachable and in the second route of entry, from impacting the stability or efficacy of the drug product.
The FDA expects the evaluation of the risk of nitrosamines in active pharmaceutical ingredients and finished drug products. This white paper describes how to conduct a nitrosamine risk assessment and perform the analysis for nitrosamines in APIs and drug products.
Transdermal delivery systems are combination products composed of multiple layers of polymer films designed to deliver a drug through the skin. Due to the complexity of design and the unique dosing regimen, evaluating extractables and leachables from a transdermal delivery system can be challenging. A draft guidance has been issued by the FDA that covers the E&L for transdermal and topical delivery systems . The experimental approach presented in this white paper represents a rational experimental approach to E&L testing of transdermal delivery systems that will satisfy FDA expectations.
To support the growing field of microbiome research, Pine Lake Laboratories has developed an assay for short chain fatty acids (acetic, butyric, and propionic acid) in human plasma. These targeted metabolites can be used as an indicator of microbiome activity in research subjects and as biomarkers to evaluate the effect of various pharmaceutical drug treatments during clinical trials. The assay uses GC-MS and can reach an LOQ of 1.00 ug/mL. for each short chain fatty acid.
Combining a surgical implant with antibiotics will present unique analytical challenges. Most notably, the combining process will likely introduce impurities and degradants not encountered in the various drug product formulations of the antibiotics. In addition, the surgical implant may have design features that need to be measured to ensure proper release of the antibiotics.
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