KRISHGEN is experienced in the development, validation and execution of biological assays within quality control of pharmaceutical and chemical products.
Many researchers are relying more on biomarkers to assess the efficacy, safety, and mechanism of action of drugs to make decisions regarding their continued development. Biomarker assesment will help ensure objective measurement and evaluation of characteristics that indicate normal biological processes, pathogenic progresses, or pharmacologic responses to a therapeutic intervention.
As biomarkers continue to gain traction in clinical research, it is essential that their validity be continuously evaluated and re-evaluated. Biomarker validity is integrally tied to biomarker performance and therefore, there has been movement towards standardization for a validation path within the industry. Validation includes proof of concept, experimental validation, analytical performances validation and protocol standardization.
|Insulin Glargine ELISA||LH (Lutenizing Hormone) Bioassay ELISA||FSH (Follicle Stimulating Hormone) Bioassay ELISA|
|hCG (human Chorionic Gonadotropin) Bioassay ELISA||KRIBIOLISA™ PEG-GCSF (Pegylated Filgrastim) ELISA|
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