Overcoming Pitfalls and Challenges with Software Validation
As a quality consultant and quality system subject matter expert in the Life Sciences Industry…
Certara2018年6月29日
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…
Certara2018年6月2日
Pharmacokinetic/ Toxicokinetic Services
As your partner for drug development and regulatory strategy, Certara has expanded its services to…
Certara2018年5月18日
What’s New in Enterprise 3.4 Q&A
Is there documented guidance on the creation of the sponsor SDTM metadata to be uploaded…
Certara2018年5月17日
Achieving Compliance with the FDA’s eCTD Mandate
The US Food and Drug Administration (FDA) has set 2018年5月5日 as the compliance…
Certara2018年5月4日
