The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...

Stay ahead of the curve with our 2nd edition Analytical Method Validation & Lifecycle Management Masterclass - US Edition. Learn about the latest ICH guidelines, including the new ICH Q14 for ...

Flow cytometry assay validation requires different analytical approaches in preclinical and clinical settings. A fit-for-purpose (FFP) strategy allows researchers to customize the validation to ...

The last two decades have witnessed the steady growth of the protein drug market. As original recombinant products come off patent, generics/ biosimilars are also beginning to be manufactured. The ...

Although phosphorylated tau at threonine 231 (pTau 231) is a promising blood-based biomarker for incipient Alzheimer's disease (AD), existing assays such as Simoa® are not sensitive enough to reliably ...

Cannabix Technologies Inc. (CSE: BLO) (OTCID: BLOZF) (Frankfurt: 8CT) (the “Company” or “Cannabix”) and Omega Laboratories Inc (“Omega”) proudly announce the peer-reviewed publication of a ...

Stay ahead of the curve with our 2nd edition Analytical Method Validation & Lifecycle Management Masterclass. Learn about the latest ICH guidelines, including the new ICH Q14 for analytical method ...