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Por supuesto:

QUALITY CONTROL 2 LEC

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Pregunta:

Should describe the knowledge that establishes that the type of dosage form selected and the formulation proposed are suitable for the intended use. It includes sufficient information in each part to provide an understanding of the development of the drug product and its manufacturing process. ASPECTS like drug substances, excipients, container closure systems, and manufacturing processes that are critical to product quality should be determined and control strategies justified.

Autor: LEIGHTON DWIGHT OBILLOS



Respuesta:

Pharmaceutical Development section


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