Designing non-clinical safety evaluation programmes for gene therapy products: A personal view

1998 ◽  
pp. 115-128
Author(s):  
James Macdonald ◽  
Richard Morrissey ◽  
James Patrick
Keyword(s):  
Gene Therapy ◽  
Safety Evaluation ◽  
Personal View ◽  
Clinical Safety

scholarly journals Preclinical Efficacy and Safety Evaluation of Hematopoietic Stem Cell Gene Therapy in a Mouse Model of MNGIE

2018 ◽  
Vol 8 ◽  
pp. 152-165 ◽  
Author(s):  
Rana Yadak ◽  
Raquel Cabrera-Pérez ◽  
Javier Torres-Torronteras ◽  
Marianna Bugiani ◽  
Joost C. Haeck ◽  
...  
Keyword(s):  
Gene Therapy ◽  
Stem Cell ◽  
Mouse Model ◽  
Safety Evaluation ◽  
Efficacy And Safety ◽  
Hematopoietic Stem ◽  
Preclinical Efficacy ◽  
Cell Gene ◽  
Stem Cell Gene ◽  
Stem Cell Gene Therapy

Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials

2007 ◽  
pp. 75-84
Author(s):  
Patricia M. Reed ◽  
Stuart J. Mair ◽  
Stephen Freestone
Keyword(s):  
Adverse Events ◽  
Phase I ◽  
Safety Evaluation ◽  
Phase I Trials ◽  
Clinical Safety

Enzymology in Preclinical Safety Evaluation

1992 ◽  
Vol 20 (3-2) ◽  
pp. 501-505 ◽  
Author(s):  
Dai T. Davies
Keyword(s):  
Enzyme Activities ◽  
Drug Effect ◽  
Safety Evaluation ◽  
Diagnostic Information ◽  
Maximum Amount ◽  
Adverse Drug Effect ◽  
Short Paper ◽  
Clinical Safety ◽  
Blood Samples ◽  
Preclinical Safety

This short paper will briefly discuss the merits of determining plasma enzyme activities in pre-clinical safety evaluation. Emphasis is placed on the value of selecting the appropriate enzymes and collecting blood samples at the appropriate times during the study, so as to gain the maximum amount of diagnostic information. Examples of actual results will be cited to illustrate some of the points. These examples are drawn from the 2 commonly used toxicology species—the laboratory white rat and the beagle—and serve to demonstrate the importance of enzymology in monitoring the progress or resolution of an adverse drug effect.

scholarly journals Safety Evaluation of Clinical Gene Therapy Using Hepatocyte Growth Factor to Treat Peripheral Arterial Disease

Hypertension ◽  
2004 ◽  
Vol 44 (2) ◽  
pp. 203-209 ◽  
Author(s):  
Ryuichi Morishita ◽  
Motokuni Aoki ◽  
Naotaka Hashiya ◽  
Hirofumi Makino ◽  
Keita Yamasaki ◽  
...  
Keyword(s):  
Gene Therapy ◽  
Growth Factor ◽  
Peripheral Arterial Disease ◽  
Hepatocyte Growth Factor ◽  
Safety Evaluation ◽  
Arterial Disease ◽  
Clinical Gene Therapy ◽  
Peripheral Arterial ◽  
Hepatocyte Growth

Pre-Clinical Safety Evaluation of Antimicrobial Bioadhesive Vaginal Formulations

2016 ◽  
Vol 14 (1) ◽  
pp. 23-27 ◽  
Author(s):  
Mohd A. Alam ◽  
Farhan J. Ahmad ◽  
Zeenat I. Khan ◽  
Roop K. Khar
Keyword(s):  
Safety Evaluation ◽  
Clinical Safety
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