HOW TO BUILD A PRODUCT MONOGRAPH?
In the medical research community or more exactly, in the pharmaceutical area a ‘Product Monograph’ produced (a factual, scientific document) that depicts the properties of a drug, its information, conditions of use for a drug necessary for safe dispensation and use. Formulated by the drug manufacturer, it may or may not be according to certain guidelines, so, it is considered as source of information about the properties of a drug. ‘Product Monograph’ prepared for new drugs, and it needs to fulfil the informative requirements of consumers.
A Product Monograph should comprise a material that conveys considerably with Scientific, Patient and Health Professional Information. The medical professionals and patients require accurate, objective and complete information on drugs approved for use to ensure safe and effective use.
The Scientific data of a product monograph constitutes elaborated data from:
- Animal studies
- Clinical trials