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Renal Impairment Studies in Early Development Services: Innovative Patient Pharmacology Models for Phase I-IIa Support

Published 19 September 2014 | By PRA Health Sciences

It is recommended to have renal impairment trials conducted relatively early in the clinical development process, because the outcome may influence the patient population as well as the inclusion and exclusion criteria of Phase II and III trials. The timing of these trials is generally before or in parallel with Phase II.

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Renal Impairment Studies in Early Development Services: Innovative Patient Pharmacology Models for Phase I-IIa Support