Biosimilar Products—A Review of Past and Current Regulatory Approval Standards for Preclinical Safety Studies

2021 ◽  
pp. 149-161
Author(s):  
A. Kimzey ◽  
K. Mease ◽  
B. Mounho-Zamora ◽  
M. Wood
Keyword(s):  
Regulatory Approval ◽  
Safety Studies ◽  
Preclinical Safety

A new automated arrhythmia detector in preclinical safety studies

2012 ◽  
Vol 66 (2) ◽  
pp. 172
Author(s):  
Philippe Michon ◽  
David Labarre ◽  
Philippe Zitoun ◽  
Florence Koeppel
Keyword(s):  
Safety Studies ◽  
Preclinical Safety

scholarly journals Biomarkers and Mechanisms of Drug-Induced Vascular Injury in Non-Rodents

2006 ◽  
Vol 34 (1) ◽  
pp. 19-26 ◽  
Author(s):  
Calvert Louden ◽  
David Brott ◽  
Anne Katein ◽  
Thomas Kelly ◽  
Sarah Gould ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Vascular Injury ◽  
Diagnostic Markers ◽  
Target Cells ◽  
Drug Selection ◽  
Primary Target ◽  
Drug Induced ◽  
Candidate Drug ◽  
Safety Studies ◽  
Preclinical Safety

In preclinical safety studies, drug-induced vascular injury can negatively impact candidate-drug selection because there are no obvious diagnostic markers for monitoring this pathology preclinically or clinically. Furthermore, our current understanding of the pathogenesis of this lesion is limited. While vasodilatation and increased shear stress appear to play a role, the exact mechanism(s) of injury to the primary target cells, smooth muscle (SMC) and endothelial cell (EC), are unknown. Evaluation of potential novel markers for clinical monitoring with a mechanistic underpinning would add value in risk assessment and risk management. This mini review focuses on the efforts and progress to identify diagnostic markers as well as understanding the mechanism of action in nonrodent drug-induced vascular injury.

Preclinical safety studies of cefmetazole

1989 ◽  
Vol 23 (suppl D) ◽  
pp. 125-129 ◽  
Author(s):  
J. B. Moe ◽  
R. C. Piper ◽  
H. Tanase ◽  
K. Sotani ◽  
J. Manabe
Keyword(s):  
Safety Studies ◽  
Preclinical Safety

scholarly journals Best Practice Approach for Assessment of Microchip-associated Tumors in Preclinical Safety Studies: Position of the Registry of Industrial Toxicology Animal-data (RITA)

2018 ◽  
Vol 46 (7) ◽  
pp. 728-734 ◽  
Author(s):  
Stefanie Lapp ◽  
Axel Bube ◽  
Florian A. Colbatzky ◽  
Heinrich Ernst ◽  
Rupert Kellner ◽  
...  
Keyword(s):  
Best Practice ◽  
Animal Data ◽  
Practice Approach ◽  
Safety Studies ◽  
Preclinical Safety ◽  
Associated Tumors
Sign in / Sign up

Export Citation Format

Share Document