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Mtoz Bolabs06 Nov, 2024Technology

Protocols: Applicants should submit stability testing protocols for review before submitting new or supplemental NADA. General Stability Considerations: This section addresses the definition of active ingredients, potency, drug preparation, chemical and physical properties, additives, product changes, relevance to efficacy and toxicity studies, degradation products, and product stability parameters. Storage Conditions: This includes specifications for shelf-life duration of studies, expiration dates, temperature settings, environmental factors, and special labeling restrictions.