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The demand for sophisticated drug delivery has led to the development of many innovative combinations of pharmaceuticals, biologics and medical devices across a broad range of therapeutic areas. While these combination products have the potential to fulfill major unmet medical needs, they also present unique challenges in development and approval. One of these challenges is the development and validation of analytical methods to assess the quality, safety and stability of combination products. This white paper will focus on the analytical methods needed for single entity combination products.
Recent changes in the FDA’s 510(k) requirements for medical device applications have spawned many inquiries from clients on how to address the request for extractables, leachables and drug compatibility data. Meeting the expectations of the CDRH can be challenging in that any given study design is not universally applicable to all devices. A good study design requires elements of the best practices documented in ISO-10993-12, the PQRI guidance for E&L testing of OINDP as well as any specific requests for drug compatibility data from CDRH.
A hybridized study design, incorporating the essential regulatory elements, has been developed and successfully implemented for a variety of medical device applications. The rationale behind selection of the elements, overall experimental design strategy and interpretation of the resulting data will be presented.
Leachables from sample container closure systems from primary and secondary packaging component that migrate into a drug products have a potentially negative impact on safety. This white paper describes how to evaluate this risk through the proper design of an extraction study and the following analysis of leachables in the drug product.
To support microbiome research, Pine Lake Laboratories has developed an assay for short chain fatty acids (acetic, butyric, and propionic acid) in feces. 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 pre-clinical and clinical trials. The method involves extracting the short chain fatty acids form feces then analysis by direct injection GC-MS.
Our experience has shown that there are points in the Quality Agreement process, by which we mean the process of drafting, approving, implementing and revising the Quality Agreement, that are particularly problematic because they require greater attention and/or pose greater risk and it is key to manage these. In this paper we describe the key steps to insure a successful quality agreement between a sponsor and a contract research organization
A method was developed and validated for the simultaneous analysis of elvitegravir, tenofovir, tenofovir Alafenamide, and tenofovir disoproxil fumarate in rabbit plasma using UPLC/MS/MS. The results of this study were presented at the 2016 AAPS National Meeting. A free reprint of this poster is available here.