Investigator Brochure
What is Investigator Brochure?
An Investigator Brochure is a document that provides essential information about a pharmaceutical product or medical device to investigators conducting clinical trials. It contains comprehensive details about the product's composition, formulation, pharmacokinetic properties, and safety profile. The Investigator Brochure serves as a valuable resource for investigators to understand and evaluate the investigational product.
What are the types of Investigator Brochure?
There are primarily two types of Investigator Brochures: Investigator's Brochure for an Investigational New Drug (IND) and Investigator's Brochure for an Approved Drug. The IND Investigator's Brochure contains information about new drugs that have not yet been approved by regulatory authorities. On the other hand, the Investigator's Brochure for an Approved Drug provides updated information about a drug that has already received regulatory approval.
How to complete Investigator Brochure
Completing an Investigator Brochure requires meticulous attention to detail. Here are the key steps to follow:
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