Why you should select your drug formulation before starting clinical studies
药物开发者常急于推进发现流程以进入人体试验。Most are…
Certara2022 年 10 月 28 日
5 steps to satisfy new EU-CTR requirements for plain language summaries of clinical study results
For the first time, the European Medicines Agency (EMA) has passed new regulations to help…
Certara2022 年 9 月 27 日
Why FDA’s new guidance on circulating tumor DNA is critical for oncology early clinical drug development
2022 is shaping up to be the “year of the guidance” as the FDA has…
Certara2022 年 7 月 1 日
Blueprint for pandemic response: Focus on translational medicine, clinical pharmacology and pharmacometrics
Perhaps the most important lesson learned from the COVID‐19 pandemic is that of preparedness. Enhanced…
Certara2021 年 5 月 11 日
Purity is a Virtue: A Practical Guide to the Reporting of Impurities
Many pharmaceutical companies struggle with characterizing drug substance (DS) and drug product (DP) impurities and…
Certara2021 年 3 月 23 日
Be honest, be reliable, be human: Insights from a global drug development expert
One of the most exciting things about working in the pharmaceutical industry is the ability…
Certara2020 年 12 月 16 日
