[HTML][HTML] Phase II trial of bevacizumab, thalidomide, docetaxel, and prednisone in patients with metastatic castration-resistant prostate cancer

…, JB Trepel, MJ Lee, YS Kim, H Sun… - Journal of clinical …, 2010 - ncbi.nlm.nih.gov
Purpose We previously demonstrated that thalidomide appears to add to the activity of
docetaxel in metastatic castration-resistant prostate cancer (CRPC). Phase II studies combining …

Migraine therapeutics in adolescents: a systematic analysis and historic perspectives of triptan trials in adolescents

H Sun, E Bastings, J Temeck, PB Smith, A Men… - Jama …, 2013 - jamanetwork.com
Objectives To conduct a systematic review and analysis of trial data submitted to the US Food
and Drug Administration (FDA) to identify possible causes for the failure of pediatric trials …

Imaging DNA synthesis with [18F]FMAU and positron emission tomography in patients with cancer

H Sun, A Sloan, TJ Mangner, U Vaishampayan… - European journal of …, 2005 - Springer
Purpose FMAU (1-(2′-deoxy-2′-fluoro-β-D-arabinofuranosyl)thymine) is a thymidine
analog that can be phosphorylated by thymidine kinase and incorporated into DNA. This first-in-…

Pulsed high-intensity focused ultrasound enhances uptake of radiolabeled monoclonal antibody to human epidermoid tumor in nude mice

A Khaibullina, BS Jang, H Sun, N Le, S Yu… - Journal of Nuclear …, 2008 - Soc Nuclear Med
The aim of this study was to determine if pulsed high-intensity focused ultrasound (HIFU)
exposures could enhance tumor uptake of 111 In-MX-B3, a murine IgG1κ monoclonal antibody …

Tumor imaging using 1-(2′-deoxy-2′-18F-fluoro-β-D-arabinofuranosyl) thymine and PET

…, KA Douglas, JM Lawhorn-Crews, H Sun… - Journal of Nuclear …, 2007 - Soc Nuclear Med
The kinetics of 1-(2′-deoxy-2′-fluoro-β-d-arabinofuranosyl)thymine (FMAU) were studied
using PET to determine the most appropriate and simplest approach to image acquisition …

Extrapolation of efficacy in pediatric drug development and evidence-based medicine: progress and lessons learned

H Sun, JW Temeck, W Chambers… - Therapeutic …, 2018 - journals.sagepub.com
Background: “Complete Extrapolation” of efficacy from adult or other pediatric data, to the
pediatric population, is an important scientific tool that reduces the need for pediatric efficacy …

Imaging DNA synthesis in vivo with 18F-FMAU and PET

H Sun, TJ Mangner, JM Collins, O Muzik… - Journal of Nuclear …, 2005 - Soc Nuclear Med
We imaged DNA synthesis in vivo with PET and 18 F-1-(2′-deoxy-2′-fluoro-β-d-arabinofuranosyl)thymine
(FMAU), which is phosphorylated by thymidine kinases and incorporated …

New strategies for the conduct of clinical trials in pediatric pulmonary arterial hypertension: outcome of a multistakeholder meeting with patients, academia, industry …

C Ollivier, H Sun, W Amchin, M Beghetti… - Journal of the …, 2019 - Am Heart Assoc
Union (EU) and the Pediatric Research Equity Act and the Best Pharmaceuticals for Children
Act in the United States aim to ensure that medicines for use in children are of high quality, …

Well-defined and reliable clinical outcome assessments for pediatric Crohn disease: a critical need for drug development

H Sun, EJ Papadopoulos, JS Hyams… - Journal of Pediatric …, 2015 - journals.lww.com
Objectives: The aim of the present study was to identify areas for further development of
clinical outcome assessment (COA) in pediatric Crohn disease (CD). Methods: The study …

Pediatric efficacy extrapolation in drug development submitted to the US Food and drug Administration 2015–2020

…, K Park, V Bhatt‐Mehta, H Sun… - The Journal of …, 2023 - Wiley Online Library
Pediatric extrapolation plays a key role in the availability of reliable pediatric use information
in approved drug labeling. This review examined the use of pediatric extrapolation in …