In the world of pharmaceutical clinical trials, success depends on many factors, but one stands out as a crucial cornerstone – robust data to meet regulatory guidelines. The Z-factor is a statistical measure used to evaluate the quality of an...
Concerns about nitrosamine impurities in foods and drugs is at an all time high. The potential health effects and the associated ethical and legal implications make it imperative for us to address this issue collectively. To assist you in navigating...
Navigating the intricate landscape of regulatory requirements and technical challenges in the pharmaceutical industry can be complex for drug manufacturers. Meeting regulatory standards, achieving accurate quantification, and ensuring sensitivity measurements are vital for your drug development journey. If you find...
A 2019 review article in the Journal of Pharmaceutical Analysis points out that protocols for peptide bioanalysis must not only be specific, multiplexing, and high-throughput, they must also minimize undesirable matrix interference effects (Pinho et al.). In fact, the authors...
A recent study from Janssen (2019) tells us that bioanalysts are switching from triple quadrupole mass spectrometry (MS) to high-resolution mass spectrometry (HRMS). While the triple quad MS, prized for its extraordinary1 sensitivity, has long been the standard analytical instrument...
To date, the Food and Drug Administration (FDA) has approved about twenty-nine biosimilars1, and the European Medicines Agency (EMA) has approved seventy-seven2 biosimilars3. Given the increased awareness and significance of biosimilars, the FDA is expected to vet and approve even...
Regulatory agencies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA) are dedicated to ensuring the safety and efficacy of drug products delivered to patients. This has led to the development of regulatory guidelines for the...
The objective of this paper is to provide an understanding of the current challenges in lipid analysis and how mass spec is rapidly evolving to address current shortcomings ...
Our Team The “Best CRO” means a service provider that is a thought leader, a specialist advisor who can quickly understand your challenges and provide actionable insights to help guide to the right solutions. Bringing Passion and Experience to Our...
Sannova fosters a collaborative work environment that upholds high scientific standards, ensuring rigor in our work while supporting and valuing our team members. We seek scientific talent who thrive in dynamic environments and offer the opportunity to collaborate with a...