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

Predictivity/Translatability of Toxicities Observed in Nonclinical Toxicology Studies to Clinical Safety Outcomes in Drug Development: Case Examples

2019 ◽  
Vol 39 (2) ◽  
pp. 141-150
Author(s):  
Nicola J. Stagg ◽  
Hanan N. Ghantous ◽  
Robert Roth ◽  
Kenneth L. Hastings
Keyword(s):  
Drug Development ◽  
Annual Meeting ◽  
Clinical Studies ◽  
Early Termination ◽  
New Drugs ◽  
Clinical Safety ◽  
Case Examples ◽  
Palm Springs ◽  
Starting Dose ◽  
Good Concordance

Nonclinical toxicology studies are conducted to characterize the potential toxicities and establish a safe starting dose for new drugs in clinical studies, but the question remains as to how predictable/translatable the nonclinical safety findings are to humans. In many cases, there is good concordance between nonclinical species and patients. However, there are cases for which there is a lack of predictivity or translatability that led to early termination of clinical studies due to unanticipated toxicities or early termination of programs before making it to the clinic due to unacceptable nonclinical toxicities assumed to be translatable. A few case examples of safety findings that are translatable versus safety findings that are not translatable and why they are not translateable were presented as a symposium at the 38th Annual Meeting of the American College of Toxicology in Palm Springs, California, and are discussed in this article.

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 an Ultra Absorbency Menstrual Tampon

2010 ◽  
Vol 19 (2) ◽  
pp. 273-278 ◽  
Author(s):  
Anne E. Hochwalt ◽  
Michaelle B. Jones ◽  
Sandy J. Meyer
Keyword(s):  
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.

Confirmation of in vitro and clinical safety assessment of behentrimonium chloride-containing leave-on body lotions using post-marketing adverse event data

2013 ◽  
Vol 27 (8) ◽  
pp. 2203-2212 ◽  
Author(s):  
D.M. Cameron ◽  
D.A. Donahue ◽  
G.-E. Costin ◽  
L.E. Kaufman ◽  
J. Avalos ◽  
...  
Keyword(s):  
Adverse Event ◽  
Safety Assessment ◽  
Event Data ◽  
Clinical Safety ◽  
Adverse Event Data ◽  
Post Marketing

Non-clinical safety assessment of gadoterate meglumine (Dotarem®) in neonatal and juvenile rats

2015 ◽  
Vol 73 (3) ◽  
pp. 960-970 ◽  
Author(s):  
Hervé Giorgi ◽  
Jennifer Ammerman ◽  
Jean-Paul Briffaux ◽  
Nathalie Fretellier ◽  
Claire Corot ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Clinical Safety ◽  
Juvenile Rats ◽  
Gadoterate Meglumine

scholarly journals Reducing attrition in drug development: Smart loading pre-clinical safety assessment

2014 ◽  
Vol 229 ◽  
pp. S167
Author(s):  
Stefan Kavanagh ◽  
Howard Mellor ◽  
Christopher Pollard ◽  
Sally Robinson ◽  
Stefan Platz ◽  
...  
Keyword(s):  
Drug Development ◽  
Safety Assessment ◽  
Clinical Safety

3 Final Report on the Safety Assessment of Nonoxynols 2, 4, 8, 9, 10, 12, 14, 15, 30, 40, and 50

1983 ◽  
Vol 2 (7) ◽  
pp. 35-60 ◽  
Keyword(s):  
Clinical Studies ◽  
Ames Test ◽  
Safety Assessment ◽  
Animal Species ◽  
Skin Irritation ◽  
Final Report ◽  
Dermal Toxicity ◽  
Rabbit Eye ◽  
Toxicity Studies ◽  
Cosmetic Ingredients

Nonoxynols are chemically stable ethoxylated alkylphenols which are chemically foaming and solubilizing agents. Estimates of the acute oral LD50s of nine of the Nonoxynols (-2 to 15) range from 0.62 to 7.4 g/kg in several animal species. Acute dermal toxicity studies in rabbits produced an LD50 range of 1.8 ml/kg to 4.4 g/kg. Skin irritation tests on rabbits indicated that Nonoxynols are nonirritating to moderately irritating. Nonoxynol compounds with short ethoxylated chains are generally severe ocular irritants, whereas long-chained Nonoxynols are only slightly irritating to the rabbit eye. No evidence of carcinogenicity was observed when Nonoxynol-4 and 9 were fed to both dogs and rats. A mutagenicity study of these two compounds by the Ames test was negative. Undiluted Nonoxynol-4 and 9 were nonirritating and nonsensitizing in clinical studies. A 50% solution of Nonoxynol-15 and/or Nonoxynol-50 produced no irritation or sensitization when tested on 168 subjects, nor was there evidence of phototoxicity when tested on a subset of this population. It is concluded that Nonoxynols 2, 4, 8, 9, 10, 12, 14, 15, 30, 40, and 50 are safe as cosmetic ingredients.

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