Development of Veterinary Immunological and Biological Products – Now and Then?

Mar 8, 2015

What are the consequences for veterinary immunological products and how may this impact on their development for registration if the regulation would be applied as currently proposed?  Dr Regina Wolf and Dr Klaus Hellmann of klifovet discuss new regulations, compare them to previous legislative solutions and analyse its different interpretations and possibilities. ...

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Foetal Sex Determination

Mar 8, 2015

Foetal sex determination using ultrasonography is being used increasingly on modern-day dairy farms and is now a valuable tool for farm animal veterinary surgeons.  in 1989, Curran et al. described an alternative method of foetal sex determination, which was carried out between days 55 and 65 of pregnancy and involved determining the location of the genital tubercle, a method now known as early foetal sex determination. Lucy Tyler from BCF Technology, explains the advantages and disadvantages of both early and late determination method. ...

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Veterinary Clinical Studies: Managing Expectations

Mar 7, 2015

Clinical studies are a vital component of development and regulatory approval of veterinary medicines for the global marketplace. In contrast to research-phase studies, which may provide a “reasonable expectation” of safety and efficacy, clinical studies for regulatory submission must “establish” safety and efficacy.  This is accomplished in large part through valid study design, documented in a comprehensive protocol.  Generation of a high-quality protocol, however, is just one aspect of meeting the stringent regulatory requirements for establishment of product safety and efficacy.  Lindsey Edwards from Triveritas talks us through many aspects of clinical study conduct and explains how to control and manage clinical studies properly. ...

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The Heart of the Matter Riding the Veterinary Learning Curve

Mar 7, 2015

As one might expect, there is a direct correlation between investigator performance and the quality of study training they receive.  What is not so apparent, though, is the extent to which training effectiveness depends on the match between training format and individual veterinarian learning styles. Denni O. Day of VetPharm, interviews specialists of the area, to discover the most efficient system of learning. ...

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