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KCAS is the first GLP laboratory to qualify all 54 biomarkers offered as a V-Plex (Validated Plex) by MSD. The a la carte style allows for customization of panels that will fit the exact needs of a study. Additionally, KCAS can perform fit-for purpose GLP …

MSD 54-plex: Ready When You Are Read More »

Several important classes of drugs are inherently unstable in biological fluids. Examples include alkylating agents, cytostatic nucleosides, drugs with ester, aldehyde, thiol, nitroxyl or lactone functional groups, and small molecule compounds with unstable metabolites, such as acylglucuronides.   The rate at which an analyte degrades …

Analysis of Unstable Compounds at KCAS Read More »

The 505(b)(2) drug development path, in contrast to traditional development of a new, never been approved drug (described under 505(b)(1) of the Federal Food, Drug, and Cosmetic Act) or ANDA (described under Section 505(j) of the Act) for a generic drug that is no longer …

505(b)(2) Drug Development: A Bioanalytical Lab’s Perspective Read More »

Tissue and tumor sample testing are valuable matrix to test for drug levels (PK) and biomarkers (PD). They are understudied in my opinion as far too many studies result in no data or uninterpretable data. The root cause is a break down in how the …

Measuring Biomarkers in Tissues Read More »

Designing a tissue assay in accordance to the FDA bioanalytical method validation (BMV) guidance involves three key questions. First, can control tissue be easily obtained in bulk quantities or should a surrogate tissue approach be considered? Second, what sample processing procedures should be considered relative …

Validating Drug Assays in Tissues Read More »