PQ/CMC Stability Study Reason Terminology

Preferred Label : PQ/CMC Stability Study Reason Terminology;

NCIt synonyms : Pharmaceutical Quality/Chemistry, Manuracturing and Controls Stability Study Reason Terminology; Pharmaceutical Quality/CMC Stability Study Reason Terminology;

NCIt definition : Terminology developed to support Study Reasons within the PQCMC Stability Data Standards.;

Alternative definition : PQCMC: This code should indicate the type of application the data supports or whether the data is submitted to an existing application. The codes indicate that the data is part of an Annual Report, New Drug Application, New Active Ingredient, Biologics License Application, Premarket Approval, or Supplement to an Approved Application.;

Details

Origin ID

C96071;

UMLS CUI

C5670985;

Semantic type(s)
- Intellectual Product [UMLS semantic type]
concept_is_in_subset
- FDA Pharmaceutical Quality/CMC Terminology [NCIt concept]
subset_includes_concept
- Abbreviated New Animal Drug Application [NCIt concept]
- Abbreviated New Drug Application [NCIt concept]
- Annual Report [NCIt concept]
- Approved Application Supplement [NCIt concept]
- Biologics License Application [NCIt concept]
- Drug Master File [NCIt concept]
- Generic Investigational New Animal Drug File [NCIt concept]
- Humanitarian Device Exemption [NCIt concept]
- Investigational Device Exemption [NCIt concept]
- Investigational New Animal Drug File [NCIt concept]
- Investigational New Drug Application [NCIt concept]
- New Active Ingredient [NCIt concept]
- New Animal Drug Application [NCIt concept]
- New Drug Application [NCIt concept]
- Pre-market Approval Application [NCIt concept]
- Premarket Device Notification [NCIt concept]

Keyword's position in hierarchy(ies) :

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