Category: G

Good Clinical Practice (GCP)

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results

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A non-binding document issued by an agency representing their current thinking on best practices.

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Grouped Submission

A grouped submission is a single submission unit that is applied to more than one submission. Grouped submissions are the only business case for sending

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Generic Drug

A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration,

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