Publications

• June 1, 2018
  

  Informing the tolerability of cancer treatments using patient-reported outcome (PRO) measures: summary of an FDA and Critical Path Institute workshop

  Kluetz PG, Kanapuru B, Lemery S, Johnson LL, Fiero M, Arscott K, Barbachano Y, Basch E, Campbell M, Cappelleri JC, Cella D, Cleeland C, Coens C, Daniels S, Denlinger CS, Fairclough DL, Hillard JR, Minasian L, Mitchell SA, O’Connor D, Patel S, Rubin EH, Ryden A, Soltys K, Sridhara R, Thanarajasingam G, Velikova G, Coons SJ. Informing the tolerability of cancer treatments using patient-reported outcome (PRO) measures: summary of an FDA and Critical Path Institute workshop. Value in Health 2018;21:742-747.

• June 1, 2018
  

  Selection of and evidentiary considerations for wearable devices and their measurements for use in regulatory decision making:  recommendations from the ePRO Consortium

  Byrom B, Watson C, Doll H, Coons SJ, Eremenco S, Ballinger R, McCarthy M, Crescioni M, O’Donohoe P, Howry C. Selection of and evidentiary considerations for wearable devices and their measurements for use in regulatory decision making:  recommendations from the ePRO Consortium.  Value in Health 2018;21:631-639.

• May 17, 2018
  

  New Collaboration Seeks to Speed Huntington’s Disease Drug Licensing

  This article originally appeared on HDBuzz and is reprinted here under Creative Commons license. Critical Path Institute launches new initiative to get HD drugs licensed as quickly as possible By Dr Jeff Carroll, Edited by Dr Ed Wild Originally published here on May 09, 2018 Recently the Critical Path Institute announced a new effort – the Huntington’s Disease...
• March 14, 2018
  

  Towards Bridging Translational Gap in Cardiotoxicity Prediction: an Application of Progressive Cardiac Risk Assessment Strategy in TdP Risk Assessment of Moxifloxacin

  Patel N, Hatley O, Berg A, Romero K, Wisniowska B, Hanna D, et al. Towards Bridging Translational Gap in Cardiotoxicity Prediction: an Application of Progressive Cardiac Risk Assessment Strategy in TdP Risk Assessment of Moxifloxacin. AAPS J. 2018 May 1;20(3):47.

• March 8, 2018
  

  Quantitative Approach for Cardiac Risk Assessment and Interpretation in Tuberculosis Drug Development

  Polak S, Romero K, Berg A, Patel N, Jamei M, Hermann D, et al. Quantitative approach for cardiac risk assessment and interpretation in tuberculosis drug development. J Pharmacokinet Pharmacodyn. 2018 Mar 8;1–11.