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
Certara University Express Webinar: Part 2: Introduction to RsNLME and overview of expanded workflow
RsNLME 简介及其群体 PK/PD 建模功能。
Certara2022 年 1 月 5 日
Certara University Express Webinar: Part 1: Introduction to RsNLME (R speaks NLME)
RsNLME 简介及其群体 PK/PD 建模功能。
Certara2022 年 1 月 5 日
Strategic Application of PBPK Modeling for Predicting DDIs & the Effects of Smoking & Organ Impairment
Olanzapine is a highly effective antipsychotic, but its uses are limited by the risk of…
Certara2021 年 12 月 23 日
Exploring Changes in SDTMIG 3.4 & ADaMIG 1.3
On November 29th 2021, CDISC released updated versions of SDTM and ADaM, including standardized structures…
Certara2021 年 12 月 16 日
Predicting and Taming Immunogenicity: Strategies for your Biologic Drug
Immunogenicity is the ability of a foreign substance, such as a drug or vaccine, to…
Certara2021 年 11 月 19 日
External Control Arms – The Case for a Standardized Lexicon and Toolkit
Both the FDA and EMA have made statements that support the concept of using real…
Certara2021 年 10 月 12 日
Model-based DDI Extrapolation Strategy from Adults to Children – A Case Study with Risdiplam
Risdiplam (EVRYSDI) is approved for the treatment of patients with spinal muscular atrophy ≥ 2…
Certara2021 年 10 月 7 日
FDA’s Digital Transformation: The Future of Technology and How to Prepare
As Life-Science manufacturers embrace new technologies to speed time to market and products become more…
Certara2021 年 10 月 5 日
