News & Events
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June 11, 2019
C-Path’s PSTC Releases Points to Consider Outlining Recommendations for Analytical Validation of Assays Used in Qualifying Biomarkers
The document serves as a guide to the analysis of biomarkers in drug development TUCSON, Ariz., June 11, 2019 — The Critical Path Institute’s (C-Path) Predictive Safety Testing Consortium (PSTC) has released a new consensus paper titled, “Points to Consider Document: Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the... -
March 26, 2019
Critical Path Instituteと医薬品医療機器総合機構、初のバイオマーカープロジェクトで協力
アリゾナ州トゥーソン、2019年1月15日 — Critical Path Institute（C-Path）は本日、Predictive Safety Testing Consortium（PSTC）と日本の医薬品医療機器総合機構（PMDA）との対面助言の結果、8つの新規尿中腎毒性バイオマーカーについて、健康な日本人ボランティアのレベルと、健康な欧米のボランティアで得られているデータをブリッジング試験で比較するという初のアプローチについて合意に達したことを発表しました。このプロジェクトの結果は、早期の臨床試験において試験参加者の安全性を確保するための意思決定の指針として、これらのバイオマーカーの活用が役立つかどうかをPMDAが評価するための臨床的エビデンスを提供するものと期待されます。
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March 26, 2019
Critical Path Institute and Japan’s Pharmaceuticals and Medical Devices Agency Collaborate on First-of-its-Kind Biomarker Project
Aim is to generate critical data to support safety decisions made in early-stage clinical trials TUCSON, Ariz., March 26, 2019 — Critical Path Institute (C-Path) announced today that a formal consultation between its Predictive Safety Testing Consortium (PSTC) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has resulted in an agreement on a first-of-its-kind... -
March 14, 2019
C-Path, FNIH Announce Clinical Development User’s Guide for Kidney Safety Biomarkers
TUCSON, Ariz., March 14, 2019 — The Critical Path Institute’s (C-Path) Predictive Safety Testing Consortium (PSTC) today announced availability of the User’s Guide: Kidney Safety Composite Measure Biomarker for Use in Clinical Development. Authored by the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium Kidney Safety Biomarker Project Team and PSTC’s... -
October 25, 2018
FNIH Biomarkers Consortium and Critical Path Institute Achieve the First Ever Qualification of a Clinical Safety Biomarker by the U.S. Food and Drug Administration
Major Milestone will Improve Detection of Drug-Induced Acute Kidney Injury in Clinical Trials. October 25, 2018 — The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium (BC) and the Critical Path Institute (C-Path) Predictive Safety Testing Consortium (PSTC) have received the first ever qualification of a clinical safety biomarker awarded by...