FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format
2025年3月19日 The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the…
Certara2025年3月19日
Rolling NDA and BLA Submissions: Accelerate Your Review Timeline
We look at the growing regulatory trend of rolling NDA and BLA submissions to help…
Certara2025年2月3日
How To Respond to Health Authority Questions
Your biotech company has just submitted the marketing application for your first drug product. It’s…
Certara2024年10月25日
Application of physiologically based pharmacokinetic modeling of novel drugs approved by the U.S. food and drug administration
The article from the European Journal of Pharmaceutical Sciences reviews the role of Physiologically Based…
Danielle Pillsbury2024年9月1日
Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates
In recent years, oncology drug developers have invested in antibody-drug conjugates (ADCs). These targeted therapies…
Certara2024年5月10日
How to Navigate the FDA Landscape for an Orphan Drug
希少疾患は公衆衛生上の優先事項です。FDA has launched several programs and a final…
Certara2024年2月21日
Certara Announces FDA Renewal and Expansion of Certara’s Biosimulation Software for Reviewing Regulatory Submissions
FDA holds more than 400 SimcypTM and PhoenixTM software licenses across 12 divisions and offices…
Jim Gallagher2021年12月21日
Mind the Gap: Best Practices in Clinical Pharmacology Gap Analysis
Do you get anxious about taking tests? Many people do because they want to show…
Certara2017年5月25日
