Why You Need an Integrated Development Plan
For a small biotech company developing its first drug asset, the path is fraught with…
Danielle Pillsbury2024 年 10 月 17 日
Why cancer drug programs need human mass balance studies
Historically, drug programs for oncology and other rapidly fatal diseases didn’t include mass balance studies…
Danielle Pillsbury2024 年 9 月 23 日
Resmetirom: A pioneering NASH clinical program
Nonalcoholic fatty liver disease (NAFLD) is a condition wherein the liver stores excess fat. Nonalcoholic…
Rajesh Krishna2024 年 8 月 23 日
Subject Exposure in Aggregate Safety Reports & Common Issues
All new and existing drugs should be safe, effective, and efficacious for the treated populations.…
Danielle Pillsbury2024 年 8 月 16 日
临床开发计划如何帮助药物项目？
Your biotechnology start-up’s candidate asset has an intriguing proof of biology. Your investors are equally…
Danielle Pillsbury2024 年 7 月 26 日
什么是科学与医学出版专业人士？
Would your drug development program benefit from partnering with experts in scientific and medical communications…
Becca Bucci2024 年 7 月 19 日
Generative AI Tools for Regulatory Writing
监管文件撰写是药物开发过程中的重要组成部分。Regulatory writers must understand…
Danielle Pillsbury2024 年 6 月 20 日
Dreaming big with standardization in clinical trial design – one biopharma’s metadata automation journey
This case study explores how one biopharma gets deeper insights & more informed decision making…
Simona Colucci2024 年 5 月 13 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…
Jim Gallagher2024 年 5 月 10 日
