Frog Embryo Teratogenesis Assay—Xenopus (FETAX): Use in Alternative Preclinical Safety Assessment

2018 ◽  
Vol 2018 (8) ◽  
pp. pdb.prot098319 ◽  
Author(s):  
Douglas J. Fort ◽  
Michael Mathis
Keyword(s):  
Safety Assessment ◽  
Frog Embryo ◽  
Preclinical Safety

scholarly journals Preclinical safety assessment of a combined vaccine against Hepatitis a virus and enterovirus 71

Vaccine ◽  
2021 ◽  
Author(s):  
Ting Yang ◽  
Baofeng Liu ◽  
Lei Yue ◽  
Tianhong Xie ◽  
Hua Li ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Hepatitis A ◽  
Hepatitis A Virus ◽  
Enterovirus 71 ◽  
Combined Vaccine ◽  
Preclinical Safety

Preclinical safety assessment of aqueous medicinal plant extracts containing thujone

2018 ◽  
Vol 295 ◽  
pp. S236
Author(s):  
C. Turek ◽  
P. Molnar-Pfitzner ◽  
N. Mörbt ◽  
M.B. Müller ◽  
P. Vögele ◽  
...  
Keyword(s):  
Medicinal Plant ◽  
Plant Extracts ◽  
Safety Assessment ◽  
Medicinal Plant Extracts ◽  
Preclinical Safety

Preclinical Safety Assessment of the 5-HT2A Receptor Agonist PET Radioligand [11C]Cimbi-36

2013 ◽  
Vol 15 (4) ◽  
pp. 376-383 ◽  
Author(s):  
Anders Ettrup ◽  
Søren Holm ◽  
Martin Hansen ◽  
Muhammad Wasim ◽  
Martin Andreas Santini ◽  
...  
Keyword(s):  
Receptor Agonist ◽  
Safety Assessment ◽  
Preclinical Safety

Preclinical Safety Assessment of a Recombinant Plague Vaccine (rF1V)

2013 ◽  
Vol 32 (5) ◽  
pp. 327-335 ◽  
Author(s):  
Jessica L. Price ◽  
T. Scott Manetz ◽  
Jeffry D. Shearer ◽  
Robert V. House
Keyword(s):  
Clinical Trial ◽  
Safety Assessment ◽  
Phase 1 ◽  
Control Material ◽  
Injection Volume ◽  
Phase 1 Clinical Trial ◽  
Human Use ◽  
Favorable Safety ◽  
Plague Vaccine ◽  
Preclinical Safety

A recombinant vaccine (rF1V) is being developed to protect adults 18 to 55 years of age from fatal pneumonic plague caused by aerosolized Yersinia pestis. A comprehensive series of studies was conducted to evaluate the general toxicity and local reactogenicity of the rF1V vaccine prior to first use in humans. Toxicity was evaluated in CD-1 mice vaccinated with control material and three dosage concentrations of rF1V with or without Alhydrogel® by intramuscular (IM) injection on Study Days 1, 29, 57 and 71 in a volume of 0.1 mL. Total immunizing protein given in each dose was 0, 20 or 60 μg/animal. Local reactogenicity was evaluated in mice at the dosages given and in New Zealand white (NZW) rabbits using the same injection volume and formulations (40, 80, 160 and 320 μg/mL total antigen and 0.3% (w/v) Alhydrogel®) intended for human use (0.5 mL). The rF1V vaccine produced no apparent systemic toxicity and only transient edema and erythema at the injection site. Together these results indicated a favorable safety profile for rF1V and supported its use in a Phase 1 clinical trial.

Preclinical safety assessment of iomeprol for injection as contrast medium for myelography

1994 ◽  
Vol 18 ◽  
pp. S43-S50 ◽  
Author(s):  
Anna La Noce ◽  
Francesco Bertani ◽  
Vito Lorusso ◽  
Franco Luzzani ◽  
Piero Tirone ◽  
...  
Keyword(s):  
Contrast Medium ◽  
Safety Assessment ◽  
Preclinical Safety
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