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Metabolism regulatory considerations

REGULATORY CONSIDERATIONS OF DRUG METABOLISM AND DRUG INTERACTION STUDIES... [Pg.203]

Consideration of the proposed indications for the candidate drug together with knowledge of its pharmacokinetics and metabolism in healthy volunteers will indicate whether specific studies in patients with impaired hepatic or renal function will be needed to be included in the Marketing Approval Application and NDA. Useful relevant guidelines are available on the FDA website and it is advisable to discuss proposals with the relevant regulatory authorities. The topic is considered in more detail in Chapter 5. [Pg.211]

Includes a timely new discussion on the regulation of cholesterol metabolism at the genetic level, with consideration of sterol regulatory element-binding proteins (SREBPs). [Pg.1129]

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Regulatory considerations

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