Brian Booth
机构:United States Food and Drug Administration, Center for Drug Evaluation and Research
发表论文 158 篇 · 总被引 6629 次 · h-index 37
代表论文
- 2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs ( Part 2 – Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity) (2019 · Bioanalysis · 被引 32)
- Land O’Lakes Workshop on Microsampling: Enabling Broader Adoption (2020 · The AAPS Journal · 被引 19)
- FDA analysis of outcomes in Asian patients (pts) with metastatic non-small cell lung cancer (mNSCLC) receiving immune checkpoint inhibitors (ICI). (2019 · Journal of Clinical Oncology · 被引 15)
- AAPS Workshop Report on ICH M10 (2019 · The AAPS Journal · 被引 11)
- FDA Approval Summary: Olutasidenib for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase 1 Mutation (2024 · Clinical Cancer Research · 被引 10)
- US Food and Drug Administration embraces using innovation to identify optimized dosages for patients with cancer (2023 · CPT Pharmacometrics & Systems Pharmacology · 被引 10)