APPLICATION OF IN VITRO TEST METHODS USING MONOLAYER AND THREE DIMENSIONAL CULTURE SYSTEMS TO EVALUATE THE IRRITANCY OF COSMETICS CONSTITUENTS

2002 ◽  
Vol 13 (2) ◽  
pp. 94
Author(s):  
H. C. Eun ◽  
D. H. Suh ◽  
K. C. Park
Keyword(s):  
Three Dimensional ◽  
Test Methods ◽  
In Vitro Test ◽  
Culture Systems ◽  
Vitro Test ◽  
Three Dimensional Culture

Animal Models and Alternatives in the Quality Control of Vaccines: Are In Vitro Methods or In Vivo Methods the Scientific Equivalent of the Emperor's New Clothes?

1995 ◽  
Vol 23 (1) ◽  
pp. 61-73
Author(s):  
Coenraad Hendriksen ◽  
Johan van der Gun
Keyword(s):  
Quality Control ◽  
Test Methods ◽  
In Vitro Test ◽  
Large Numbers ◽  
Alternative Approach ◽  
Inactivated Vaccines ◽  
Vitro Test

In the quality control of vaccine batches, the potency testing of inactivated vaccines is one of the areas requiring very large numbers of animals, which usually suffer significant distress as a result of the experimental procedures employed. This article deals with the potency testing of diphtheria and tetanus toxoids, two vaccines which are used extensively throughout the world. The relevance of the potency test prescribed by the European Pharmacopoeia monographs is questioned. The validity of the potency test as a model for the human response, the ability of the test to be standardised, and the relevance of the test in relation to the quality of the product are discussed. It is concluded that the potency test has only limited predictive value for the antitoxin responses to be expected in recipients of these toxoids. An alternative approach for estimating the potency of toxoid batches is discussed, in which a distinction is made between estimation of the immunogenic potency of the first few batches obtained from a seed lot and monitoring the consistency of the quality of subsequent batches. The use of animals is limited to the first few batches. Monitoring the consistency of the quality of subsequent batches is based on in vitro test methods. Factors which hamper the introduction and acceptance of the alternative approach are considered. Finally, proposals are made for replacement, reduction and/or refinement (the Three Rs) in the use of animals in the routine potency testing of toxoids.

Animal, human, and in vitro test methods for predicting skin irritation

2012 ◽  
pp. 268-273
Author(s):  
Yakir S. Levin ◽  
Cheryl L. Levin ◽  
Howard I. Maibach
Keyword(s):  
Skin Irritation ◽  
Test Methods ◽  
In Vitro Test ◽  
Vitro Test

An update on in vitro test methods in human hepatic drug biotransformation research: pros and cons

2003 ◽  
Vol 189 (3) ◽  
pp. 233-246 ◽  
Author(s):  
Esther F.A Brandon ◽  
Christiaan D Raap ◽  
Irma Meijerman ◽  
Jos H Beijnen ◽  
Jan H.M Schellens
Keyword(s):  
Test Methods ◽  
In Vitro Test ◽  
Hepatic Drug ◽  
Drug Biotransformation ◽  
Pros And Cons ◽  
Vitro Test
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