FDA’s New ANDA Submissions Guidance: Key Points
The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance…
CertaraSeptember 27, 2018
How to Use a Reference-scaled Average Bioequivalence Approach for Narrow Therapeutic Index Drugs
Watch this webinar to learn how RSABE for NTIDs can be performed in Phoenix WinNonlin…
CertaraSeptember 25, 2018
Certara Professional Certification Program
Certara Professional Certification is an online accreditation of user competency and proficiency in analysis of…
CertaraAugust 21, 2018
Using IVIVC to Optimize Your Drug Formulation After a Failed BA/BE Study
This webinar introduced how IVIVC can be used to get your drug program back on…
CertaraJuly 18, 2018
Overcoming Pitfalls and Challenges with Software Validation
As a quality consultant and quality system subject matter expert in the Life Sciences Industry…
CertaraJune 29, 2018
Apixaban for treatment of venous thromboembolism (VTEtx): Use of MBMA to support Phase 3 dose selection and beyond
Apixaban is an orally available, direct, selective inhibitor of the coagulation factor Xa that reversibly…
CertaraJune 2, 2018
