Preclinical safety evaluation and dose-setting for first-in-human studies with novel protein therapeutics: ABPI/BIA early stage clinical trials taskforce report

Toxicology ◽  
2007 ◽  
Vol 240 (3) ◽  
pp. 153
Author(s):  
Jenny Sims
Keyword(s):  
Clinical Trials ◽  
Early Stage ◽  
Safety Evaluation ◽  
Protein Therapeutics ◽  
Human Studies ◽  
Preclinical Safety ◽  
Novel Protein

Preclinical safety evaluation of nafithromycin (WCK 4873) with emphasis on liver safety in rat and dog

2021 ◽  
Vol 122 ◽  
pp. 104889
Author(s):  
Manohar Nandanwar ◽  
Rajesh Chavan ◽  
Atul Kansagara ◽  
Muftedar Ahmed Patel ◽  
Anasuya Patel ◽  
...  
Keyword(s):  
Safety Evaluation ◽  
Liver Safety ◽  
Preclinical Safety

scholarly journals Platelets as messengers of early-stage cancer

2021 ◽  
Author(s):  
Siamack Sabrkhany ◽  
Marijke J. E. Kuijpers ◽  
Mirjam G. A. oude Egbrink ◽  
Arjan W. Griffioen
Keyword(s):  
Tumor Angiogenesis ◽  
Blood Test ◽  
Early Stage ◽  
Human Studies ◽  
Early Stage Cancer ◽  
Reciprocal Interaction ◽  
Early Stages ◽  
New Strategy ◽  
Mrna Content

AbstractPlatelets have an important role in tumor angiogenesis, growth, and metastasis. The reciprocal interaction between cancer and platelets results in changes of several platelet characteristics. It is becoming clear that analysis of these platelet features could offer a new strategy in the search for biomarkers of cancer. Here, we review the human studies in which platelet characteristics (e.g., count, volume, protein, and mRNA content) are investigated in early-stage cancer. The main focus of this paper is to evaluate which platelet features are suitable for the development of a blood test that could detect cancer in its early stages.

scholarly journals Placental Mesenchymal Stromal Cells: Preclinical Safety Evaluation for Fetal Myelomeningocele Repair

2021 ◽  
Vol 267 ◽  
pp. 660-668
Author(s):  
Jordan E Jackson ◽  
Christopher Pivetti ◽  
Sarah C Stokes ◽  
Christina M Theodorou ◽  
Priyadarsini Kumar ◽  
...  
Keyword(s):  
Mesenchymal Stromal Cells ◽  
Stromal Cells ◽  
Safety Evaluation ◽  
Myelomeningocele Repair ◽  
Preclinical Safety

scholarly journals BIPOLAR MULTI-ELECTRODE BALLOON CATHETER RADIOFREQUENCY RENAL DENERVATION WITH THE VESSIX SYSTEM: PRECLINICAL SAFETY EVALUATION

2014 ◽  
Vol 63 (12) ◽  
pp. A2085
Author(s):  
Gregory J. Wilson ◽  
Dawn Winsor-Hines ◽  
Radhika Tunstall ◽  
Barbara Huibregtse ◽  
Liza Davis ◽  
...  
Keyword(s):  
Renal Denervation ◽  
Balloon Catheter ◽  
Safety Evaluation ◽  
Preclinical Safety

Preclinical safety evaluation of human platelets treated with antimicrobial peptides in severe combined immunodeficient mice

Transfusion ◽  
2013 ◽  
Vol 54 (3) ◽  
pp. 569-576 ◽  
Author(s):  
Marta Bosch-Marcé ◽  
Ketha V.K. Mohan ◽  
Monique P. Gelderman ◽  
Patricia L. Ryan ◽  
Estelle Russek-Cohen ◽  
...  
Keyword(s):  
Antimicrobial Peptides ◽  
Safety Evaluation ◽  
Human Platelets ◽  
Immunodeficient Mice ◽  
Preclinical Safety

scholarly journals Point/counterpoint: early-stage Hodgkin lymphoma and the role of radiation therapy

Hematology ◽  
2012 ◽  
Vol 2012 (1) ◽  
pp. 313-321 ◽  
Author(s):  
Ralph M. Meyer ◽  
Richard T. Hoppe
Keyword(s):  
Clinical Trials ◽  
Radiation Therapy ◽  
Hodgkin Lymphoma ◽  
Early Stage ◽  
Trial Protocol ◽  
Radiation Oncologist ◽  
Limited Stage ◽  
Considerable Debate

Abstract The results of recent clinical trials for the management of limited-stage Hodgkin lymphoma have led to considerable debate, especially regarding the role of radiation therapy. This review highlights those recent trials and provides perspectives regarding their interpretation from a radiation oncologist and a hematologist. The trial protocol is available at http://www.nejm.org/doi/suppl/10.1056/NEJMoa1111961/suppl_file/nejmoa1111961_protocol.pdf.

Sign in / Sign up

Export Citation Format

Share Document