Term
Common Technical Document (CTD) |
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Definition
The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. CTD formate is not required in the United States; however, the information in an NDA is identical to that of CTC
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Term
Modules of Common Technical Document |
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Definition
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Module 1 - Regional Administravie Information (not part of CTD)
Module 2 - Quality Overall Summary
Module 3 - Quality
Module 4 - Non-clinical Study Reports
Module 5 - Clinical Study Reports |
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Term
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Definition
New Drug Applicaton (FDA)
The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA. |
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Term
Abbreviated New Drug Application (ANDA): Generics |
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Definition
- ANDA contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
- Once approved, an applicant may manufacture and market the generic drug product.
- A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.
- Generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.
- must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug) by measuring the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers.
- must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug.
- Using bioequivalence as the basis for approving generic copies of drug products was established by the "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the Waxman-Hatch Act.
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