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Plant Pathology & Quarantine 13(1): 7583 (2023)
www.ppqjournal.orgISSN 22292217Article
DOI 10.5943/ppq/13/1/8Validation of a generic model for predicting garlic rust
Mailman G1, Fernandes JMC2, Monterey
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What is validation of a generic?
Validation of a generic refers to the process of ensuring that a generic drug meets the specific regulatory standards set by health authorities, confirming its safety, efficacy, and quality compared to the branded counterpart.
Who is required to file validation of a generic?
Manufacturers or sponsors of generic drug products are required to file validation of a generic with the appropriate regulatory authorities.
How to fill out validation of a generic?
To fill out validation of a generic, the manufacturer must complete a specific form provided by the regulatory authority, include necessary data on the drug's composition, manufacturing processes, and comparative studies with the branded drug.
What is the purpose of validation of a generic?
The purpose of validation of a generic is to ensure that the generic drug is therapeutically equivalent to its branded version, thereby assuring patients and healthcare providers of its efficacy and safety.
What information must be reported on validation of a generic?
Information that must be reported includes drug composition, bioequivalence studies, manufacturing processes, labeling, and any safety data relevant to the generic product.
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