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What’s behind the Data Sheet?
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Introduction:
A new product arrives on the market: how can you assess it? This presentation will examine the additional sources of information and what they can provide to enable you to make an objective assessment.
Sources of information
A data sheet is an abbreviated version of the summary of product characteristics: a document that describes the profile of a veterinary product. With the launch of a new product there are typically a number of leaflets and other commercial literature produced. These provide useful information but are likely to focus on the benefits of the new treatment.
The treatment or at least the active ingredient may have a previous history. For example, many of the active ingredients that are used as ectoparasiticides have been used as pesticides in agriculture or horticulture so appear in publications such as the Pesticide Manual. This provides a summary of applications for the chemical, physical chemistry and toxicology. Where the treatment has already been licensed in human medicine there may be articles in peer-reviewed journals. Even when the product contains a new molecule such as was the case with emodepside or metaflumizone, a literature search is likely to reveal publications relating at least to early investigations into pharmacological activity.
When a submission for approval of a new medicine is made to the European Medicines Agency (EMEA), they produce a critical review of the data (an EPAR) that were submitted to support the quality, safety and efficacy of the product and this review is published on the EMEA website (www.emea.europa.eu). The report may extend up to a document of 20 or more pages and summarises each study conducted to demonstrate some quality of the product. In the US, information about veterinary medicines may be found within the freedom of information documentation (www.fda.gov/foi).
At an early stage of development, the developers of the veterinary medicine will have referred to various guidelines for expectations on the required level of efficacy and the type of tests that need to be conducted. These include good clinical practice guidelines (VICH GCP), good laboratory practice (GLP) guidelines and other guidelines that can be found on the EMEA website.
Examples will be provided of how these sources of information can be used to build up a picture of a new product.
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