Moreover, drug authorities are one of the most stringent government functionary in almost all the countries and a company can't simply get a license to manufacture or even distribute inferior biologicals. World Health Organization & World Animal Health organization have made certain recommendations for minimum standards including International Units after studying field conditions. ( We are not citing those references here as this may trigger more field arguments into which we don't want to engage. ) Our general perception is that almost all rabies vaccines in the market satisfy these requirements. Of course, we agree that some production batch may go off the track and enter the market to which immune response may be negative. How come then the claims on I.U valid in the market ? WHO / WAHO recommendation implies that those specifications should be met at the time of using the product. This doesn't have any major implications on the pharmaceutical aspect of biologicals production. Often a fact ignored is " overages ", which simply means that most of the pharmaceutical products have an 'extra' active constituent to satisfy the label claim till the shelf life. Consider that a product leaves the factory with a label claim of ' x ' mg. Assume that the label also says it has got 3 yrs of shelf life. ( Note: Shelf life is calculated through experiments including "Accelerated Stability Studies" as companies can't wait for years to find the actual expiry dates ! ) Now the question is, when you buy this product within a few days, of course, you get the label claim of ' x ' mg. Imagine what happens if your friend buys the same product after 2 years and 11 months, does it contain the same strength? Certainly not, because of continuous degradation. November 2006 |
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