Certificate of Analysis Essentials for Regulated Bioanalysis скачать в хорошем качестве

Certificate of Analysis Essentials for Regulated Bioanalysis

In this webinar, we discuss reference standards, characterization requirements, and how to interpret routine test results displayed in a certificate of analysis. Reference standard materials are routinely used in regulated bioanalysis for a number of reasons. The required quality level and degree of characterization of the reference standard will depend on the stage of drug development and regulatory expectations. It is important to understand the information provided within a reference standard certificate of analysis to evaluate if requirements are met. The data and test results most often provided within a certificate of analysis will be explained. In addition, pointers will be given as to what to look for in the information provided to avoid bioanalytical issues down the line. What will you learn: • What is a reference standard? • Why use a reference standard in regulated bioanalysis? • What information is contained in a reference standard CoA? • How to interpret the data from the CoA? Who may this interest? • Quality Assurance personnel • Bioanalytical Principal Investigators and teams • Employees handling reference standard material Focused on your needs, our bioanalytical specialists provide exceptional precision bioanalytical services for a wide range of study types — working with you to accelerate development, meet your milestones, and ensure compliant, on-time regulatory submissions for your drug candidates. Our team of dedicated bioanalytical scientists works with the latest equipment to provide bioanalytical services from discovery to preclinical and clinical pharmacology, in accordance with GLP and current FDA/EMA guidelines for both small and large molecules, including immunogenicity and biomarkers. Each bioanalytical validation and bioanalytical phase for sample analysis has an assigned Bioanalytical Principal Investigator. Altasciences is an integrated drug development solution company, offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to their preclinical and clinical study needs. From lead candidate selection to proof of concept, we offer one-stop integrated formulation, preclinical and clinical manufacturing and analytical services. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, and data management, all of which can be tailored to specific sponsor requirements. Visit our website to learn more: https://www.altasciences.com/ #Altasciences #ScientificResearch #Pharmacology