Why you should select your drug formulation before starting clinical studies
Drug developers often rush through the discovery process to get into human testing. Most are…
CertaraOctober 28, 2022
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…
CertaraSeptember 27, 2022
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…
CertaraJuly 1, 2022
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…
CertaraMay 11, 2021
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…
CertaraMarch 23, 2021
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…
CertaraDecember 16, 2020
Optimize Immuno-oncology Drug Discovery and Development Using QSP
A Quantitative Systems Pharmacology (QSP) approach for developing combination immune-oncology therapies can be used to…
CertaraJune 19, 2019
