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Regulations and procedures in parasite vaccine development

Published online by Cambridge University Press:  02 February 2007

TH. P. M. SCHETTERS  and
M. GRAVENDYCK
TH. P. M. SCHETTERS
Affiliation:
Parasitology R&D Department, Intervet International, P.O. Box 31, 5830 AA, Boxmeer, The Netherlands
M. GRAVENDYCK
Affiliation:
Registration Department, Intervet International, P.O. Box 31, 5830 AA, Boxmeer, The Netherlands
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Abstract

Although immunisation protocols for a wide variety of parasitic diseases have been developed, it is often questioned why these do not always reach the market. In this review information about the regulations and procedures that apply to licensing the production and marketing of medicinal preparations, especially parasite vaccines, is presented. These general regulations specify issues on product (quality, safety, efficacy and potency) and production (facilities and consistency). Vaccine developers and manufacturers have to comply with these regulations, which may involve years of research and development. Moreover, where the manufacturer claims specific features of the product, these claims have to be corroborated by (experimental) data. A series of principles has been used to develop vaccines against parasite infections varying from the use of (attenuated) live vaccines to killed vaccines and subunit vaccines. The implications of some specific regulatory issues associated with these approaches are discussed.

Keywords

Vaccinedevelopmentmanufacturerequirementsguidelinesparasite
Type
Research Article
Information
Parasitology , Volume 133 , Supplement S2: Parasite Vaccines , October 2006 , pp. S189 - S195
Copyright
© 2006 Cambridge University Press

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