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...... -
May 2, 2019
C-Path, CDISC Release Therapeutic Area Standard to Drive Research Forward for Clostridium Difficile Associated Diarrhea
TUCSON, Ariz. and AUSTIN, May 2, 2019 — The Critical Path Institute (C-Path) and CDISC are pleased to announce the release of a global Therapeutic Area Standard, which describes how to use CDISC standards to represent data in research studies pertaining to Clostridium difficile associated diarrhea (CDAD). The standard, released in the form of a...... -
April 16, 2019
C-Path, CDISC Develop Therapeutic Area Standard to Foster More Efficient and Meaningful Research for HIV
TUCSON, Ariz. and AUSTIN, April 16, 2019 — The Critical Path Institute (C-Path) and CDISC are pleased to announce the release of a global Therapeutic Area Standard that specifies how to structure commonly collected data and outcome measurements in clinical trials for HIV. The standard, released in the form of User Guide for data...... -
April 9, 2019
C-Path Receives Qualification from FDA for the Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD)
TUCSON, Ariz., April 9, 2019 — Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium announces U.S. Food and Drug Administration (FDA) qualification of two new clinical outcome assessment tools: the Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD). The qualification of the ADSD and the ANSD represents a major milestone...... -
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。