scholarly journals Cardiovascular Safety Assessment in Early‐Phase Clinical Studies: A Meta‐Analytical Comparison of Exposure‐Response Models

2016 ◽  
Vol 5 (6) ◽  
pp. 324-335 ◽  
Author(s):  
DJ Conrado ◽  
D Chen ◽  
WS Denney
Keyword(s):  
Clinical Studies ◽  
Early Phase ◽  
Safety Assessment ◽  
Cardiovascular Safety ◽  
Response Models ◽  
Analytical Comparison ◽  
Exposure Response

1 Final Report on the Safety Assessment of Isostearyl Neopentanoate

1985 ◽  
Vol 4 (3) ◽  
pp. 1-22 ◽  
Keyword(s):  
Test Data ◽  
Clinical Studies ◽  
Safety Assessment ◽  
Final Report ◽  
Cosmetic Products ◽  
Short And Long Term ◽  
Cosmetic Formulation

Isostearyl Neopentanoate, the ester of Isostearyl Alcohol and Neopentanoic Acid, is used in cosmetic products as an emollient at concentrations up to 50 percent. The undiluted ingredient at doses up to 4 ml/kg was shown to be relatively non-toxic in short-and long-term feeding studies. Test data from animal and clinical studies indicate the undiluted ingredient is neither an irritant nor a sensitizer. A cosmetic formulation containing 16 percent Isostearyl Neopentanoate produced no phototoxicity and no photoallergenicity. Mutagenicity, carcinogenicity, and teratogenicity data were not available. Isostearyl Neopentanoate was not considered to be a significant comedogenic agent. On the basis of available data, it is concluded that this ingredient is safe as a cosmetic ingredient in its present practices of use.

Clinical safety assessment of iotrolan 280 in European clinical studies

1995 ◽  
Vol 5 (S2) ◽  
pp. S85-S88 ◽  
Author(s):  
O. M. Silvay-Mandeau ◽  
C. Meissner ◽  
B. I. Wenzel-Hora
Keyword(s):  
Clinical Studies ◽  
Safety Assessment ◽  
Clinical Safety

scholarly journals 10 Final Report on the Safety Assessment of Cholesterol

1986 ◽  
Vol 5 (5) ◽  
pp. 491-516 ◽  
Keyword(s):  
Clinical Studies ◽  
Safety Assessment ◽  
Final Report ◽  
Experimental Animals ◽  
Normal Metabolism ◽  
Hair Care ◽  
Uvb Exposure ◽  
High Doses ◽  
Skin Irritants

Cholesterol is used as an emulsifier in cosmetic skin and hair care products and eye and face makeup formulations at concentrations up to 5%. The normal metabolism and excretion of Cholesterol is well documented in man and experimental animals. Cholesterol is not a significant dermal or ocular irritant. Cholesterol does not appear to have any genotoxic activity in bacterial or mammalian cell in vitro mutagenic and transformation assays. High doses of Cholesterol were teratogenic in rats. Cholesterol has not been established as a promoter, cocarcinogen, or total carcinogen. Clinical studies to evaluate the safety of topically applied Cholesterol were restricted to products formulated with the ingredient. Most products were moisturizers containing 1.4% Cholesterol. The highest concentration of Cholesterol tested (6%) was evaluated in a modified prophetic test (110 subjects) and an RIPT (45 subjects); both assays had UVA and UVB exposure incorporated into the protocols. The Cholesterol-containing products were minimal to mild primary and cumulative skin irritants but not sensitizers or photosensitizers.

scholarly journals Current and future approaches to nonclinical cardiovascular safety assessment

2020 ◽  
Vol 25 (7) ◽  
pp. 1129-1134 ◽  
Author(s):  
Teresa A. Collins ◽  
Michael G. Rolf ◽  
Amy Pointon
Keyword(s):  
Safety Assessment ◽  
Cardiovascular Safety

Extemporaneous preparation strategy for early phase clinical studies

2018 ◽  
Vol 549 (1-2) ◽  
pp. 150-160 ◽  
Author(s):  
Rampurna P. Gullapalli ◽  
Carolyn L. Mazzitelli ◽  
Christina M. Charriez ◽  
David J. Carpenter ◽  
Rebecca D. Crean ◽  
...  
Keyword(s):  
Clinical Studies ◽  
Early Phase ◽  
Extemporaneous Preparation ◽  
Preparation Strategy
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