What Oncology Drug Developers Should Expect from the FDA’s Project Optimus
一直以来，肿瘤药物的剂量策略都以最大耐受剂量为重点。This…
Certara2022 年 1 月 13 日
PBPK Modeling of Antibody-Drug Conjugates – Concept and Application
Antibody-Drug Conjugates (ADCs) can be an ideal drug treatment for cancer because they deliver a…
Certara2022 年 1 月 13 日
Developing Targeted Covalent Inhibitor Drugs: 3 Key Considerations
Traditional mechanisms of drug action rely on the reversible, noncovalent interaction of a ligand with…
Certara2021 年 11 月 5 日
Accelerating ADCs’ development pipeline using Simcyp PBPK
With nearly 10 million deaths in 2020 and despite great progress, cancer remains the leading…
Certara2021 年 10 月 15 日
PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib
Cobimetinib (Cotellic®), approved by the US FDA in 2015, is a kinase inhibitor for treating…
Certara2021 年 8 月 12 日
DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®)
Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare…
Certara2021 年 7 月 29 日
Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success
Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an…
Certara2021 年 7 月 8 日
Strengths and opportunities for HTAs and market access in Europe through case studies
Amongst the real world data sources in Europe, the French Healthcare database SNDS is the…
Certara2021 年 5 月 26 日
Mechanistic quantitative pharmacology strategies for the early clinical development of bispecific antibodies in oncology
Bispecific antibodies (bsAbs) have become an integral component of the therapeutic research strategy to treat…
Certara2020 年 7 月 14 日
