White Paper: Pacific Biomarkers
In order to enhance patient safety and improve the quality of testing performed in laboratories, there is a need for integrating good laboratory practices. There are many areas and processes that a laboratory should consider before adding waived testing to the panel of services.
Incorporating FDA GLP capabilities into CAP/clinical facility poses certain challenges. Starting a FDA GLP compliant facility from scratch or bringing FDA GLP compliant capabilities into a facility that is already established under a different set of regulations or practices is challenging.
So what are the common challenges in implementing regulations for good laboratory practices and how can they be overcome?
Read this whitepaper to know about the common queries on more advanced topics related to integrating good laboratory practice.
How can we incorporate CAP and FDA GLP compliant testing in the same space?
What are the models used by a facility for incorporating FDA GLP capabilities into its CAP / clinical facility?
What are the activities associated with good laboratory practices?
Download this whitepaper now to learn more about FDA GLP and CAP regulations for integrating good laboratory practices in your clinical facility.
By: Pacific Biomarkers
Preanalytical considerations in the design of clinical trials and epidemiologic studies are the cornerstones of the biochemical analyses. The main subject of clinical study design and epidemiology research is to monitor health, detect the harmful side effects and study the impact of therapeutic interventions. However, the largest contribution of errors in the clinical study design and epidemiology is associated with preanalytical phase. Do you think preanalytical variables are given sufficient consideration when designing clinical trials or epidemiologic studies? What strategies can be used to minimize preanalytical variables in clinical trials or epidemiologic studies? Is there a technology or a process to improve stability of sample analytes so that future investigations will not suffer from poor sample quality? What are the common challenges encountered during the preanalytical phase? This whitepaper discusses the factors to be considered during clinical trial designing and challenges faced during preanalytical phase such as: Availability of limited resources during the clinical designing. Technology and storage processes used to store the biomarker samples. Time elapsed between the sample collection and the stabilizing agents used to store the samples. Download this whitepaper with a brief insight into the issues of preanalytical variables and how they impact the clinical trial design and epidemiologic studies.
By: Pacific Biomarkers
Testing for incretins, and other gut hormones, presents numerous challenges because of their instability. Therefore, proper sample collection and meticulous pre-analytical and analytical sample handling are crucial for successful quantification of these biomarkers. Incretins, which are insulinotropic gastrointestinal hormones, are produced mainly in K and L cells of the small intestine under the influence of nutritional stimuli. This insightful whitepaper sees into queries like: What are the significant challenges in the measurement of incretins and gut hormones? What is the best practice for minimizing pre-analytical variability associated with blood collection, processing and storage? What are the additional pre-analytical steps that should be considered when samples are obtained for quantification of active acylated ghrelin? Download this whitepaper that provides insights about the challenges, best practices and major concerns regarding commercial assays for reliable quantification of incretins and gut hormones and specific pre-analytical and analytical processes as well as data analysis to improve sensitivity.