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Read article Evaluating New Modalities

Measuring new biotherapeutic modalities such as cellular therapies are not well defined in the regulatory landscape. Currently no white papers or guidelines are available to help navigate the murky waters of quantifying new modalities, which is why the AAPS PK focus group has set a course toward providing the field…

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Read article Quality Assurance at KCAS

In pursuit of KCAS’ Mission to provide reliable and defendable data, quality is one of our core values. It is the responsibility of every employee to provide an always improving, high-level performance in all we do. Our independent Quality Assurance Unit (QAU) assures management that Operations is performing in conformance…

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Read article The Value of Deuterated Internal Standards

Surprisingly, there are a number of drug development companies that do not obtain stable isotope-labeled internal standards (SIL-IS) for their bioanalytical methods. Instead they settle for using a surrogate internal standard (a compound that closely resembles the measured analyte) which can lead to unreliable data and be detrimental to a…

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Read article Optimizing ELISA Kits for Biomarkers at KCAS

What you don’t know about how an off-the-shelf Biomarker kit is evaluated and qualified can significantly compromise your biomarker data. Running the kit using the manufacturer’s instructions without systematically testing the accuracy/precision (A/P), range of quantification (ROQ), dilutional linearity (DL), stability, and selectivity can jeopardized the interpretation of the results.

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Read article Feasibility Studies at KCAS: Avoiding Unwanted Surprises

Like the old adage, “you get out of it what you put into it,” good study design is a prerequisite of good data. To boost the chances of generating accurate and informative facts over the course of a study, it is key to consider all of the supporting parameters that…

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Read article Pharmacokinetics at KCAS: An Orchestrated Approach

Finding a laboratory to successfully transfer and GLP validate your PK method can be a challenge. Yes sure the big labs can do it, but if you are not a preferred provider you may find yourself working with the B team that doesn’t move as fast as you need, and…

PATTERN_AMBER_1320x780 Blogs
Read article Applying GLP Standards to Sub-Ambient Sample Storage at KCAS

There is regulatory requirement that the cumulative time a frozen pharmacokinetic sample has been thawed – from the time it’s removed from the freezer to the time it’s returned – be documented. Freeze/thaw cycle data is not deemed sufficient alone, since a study sample might have been thawed for extended…

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Read article Flow Cytometry: Tailored Solutions without Additional Qualification

The challenges and obstacles to including flow cytometry in multi-center clinical trials are well-known. The solutions the KCAS team offers can eliminate risks commonly associated with lost or delayed shipments and allow for batching, which reduces the overall cost of conducting flow cytometric testing. As a result, our customers can…

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Read article Common Rule – Who decides what happens to your samples?

The Department of Health and Human Services (HHS) has issued long awaited, comprehensive update on how medical research should be conducted. The Common Rule, 45 CFR 46 subpart A, issued 26 years ago and established basic protections for human subjects in research conducted by or supported by the HHS and…

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Read article Boutique CROs: Being David in a land of Goliaths

In today’s drug development arena, massive, multinational CROs dominate the industry. They offer a “one stop shop” suite of services covering Early Development to Phase IV Clinical Trials and everything in between. Although multinational…