Qualification of Biomarkers for Drug Development in Organ Transplantation-Reference-Cited by-同舟云学术

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Qualification of Biomarkers for Drug Development in Organ Transplantation

Published:2007-12-18 Issue:2 Volume:8 Page:267-270
ISSN:1600-6135
Container-title:American Journal of Transplantation
language:en
Short-container-title:

Author:

Burckart Gilbert J.,Amur Shashi,Goodsaid Federico M.,Lesko Lawrence J.,Frueh Felix W.,Huang Shiew-Mei,Cavaille-Coll Marc W.

Publisher

Wiley

Subject

Pharmacology (medical),Transplantation,Immunology and Allergy

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/j.1600-6143.2007.02063.x/fullpdf

Reference15 articles.

1. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework;Biomarkers Definitions Working Group;Clin Pharmacol Ther,2001

2. Biomarkers and surrogate endpoints in renal transplantation: Present status and considerations for clinical trial design;Lachenbruch;Am J Transplant,2004

3. Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs;Wagner;Clin Pharmacol Ther,2007

4. Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: Criteria, validation, strategies;Lesko;Annu Rev Pharmacol Toxicol,2001

5. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era;Meier-Kriesche;Am J Transplant,2004

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2. Banff 2019 Meeting Report: Molecular diagnostics in solid organ transplantation–Consensus for the Banff Human Organ Transplant (B‐HOT) gene panel and open source multicenter validation;American Journal of Transplantation;2020-06-27

3. Late Graft Loss After Kidney Transplantation: Is “Death With Function” Really Death With a Functioning Allograft?;Transplantation;2019-09-13

4. Living Donor Liver Transplantation for Hepatocellular Carcinoma: An Asian Perspective;Digestive Diseases and Sciences;2019-03-20

5. Regulatory Aspects of Pediatric Biomarkers for Assessing Medication Response;Personalizing Asthma Management for the Clinician;2018

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