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Few instructions to build a Product Monograph

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:

  • Toxicology
  • Animal studies
  • Clinical trials
  • Ph
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Clinical Data Management and CDISC standards

Pharmaceutical Clinical Data Management:

Many pharmaceutical and biotechnology companies are working on the development of new drugs, compounds and devices for betterment of human health and increase the quality of life globally. This process of drug development and discovery when reaches the stage of testing in human volunteers involves people from various specialty and varied background. Final goal of any human trial is to be able to investigate the safety and efficacy of the investigative compound or device in human subjects within the regulatory guidelines and accepted standards of safety, patient care and data interpretation.

The initial stage of any clinical study involves the collection of observational, laboratory and other data of the trail subjects and is the most critical part in the study life cycle. It is this collected data, which will be used in analyzes of final end points of any study. The quality of data and accuracy then becomes most important thing. The greater

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