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ABCD Protocol for observational studies based on existing data TITLE PAGEDocument Number:c0327072608BI Study Number:1245.96BI Investigational Product(s): (empagliflozin) Synjardy (empagliflozin/)Title:Postauthorisation

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What is bi investigational?

BI investigational refers to the processes and protocols involved in the investigation of biologics for safety, efficacy, and quality, often conducted during clinical trials.

Who is required to file bi investigational?

Entities conducting clinical trials involving biologics, including pharmaceutical companies and research institutions, are required to file BI investigational applications.

How to fill out bi investigational?

To fill out a BI investigational application, submit required forms detailing the biologic's properties, clinical trial design, safety data, and proposed patient population to the relevant regulatory authority.

What is the purpose of bi investigational?

The purpose of BI investigational is to ensure that biologic products are studied rigorously to determine their safety and effectiveness before being approved for public use.

What information must be reported on bi investigational?

BI investigational applications must report information on the product's composition, manufacturing process, pre-clinical data, trial design, ongoing and completed studies, and safety monitoring procedures.

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