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(two) Perseverance of conformance to published specifications and a description of sampling and tests strategies for in-procedure components. This kind of samples shall be consultant and effectively identified. indicates An important deviation from GMP or GDP or in the conditions of the manufactu

eight. The most important metabolism pathway for zileuton in cynomolgus monkey and human is glucuronidation for the N- Prodrugs are a category of drugs administered in a very pharmacologically inactive form that is enzymatically or chemically remodeled into a pharmacologically active form in vivo

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