Document Report Card

ID: ALA3508693

Title: FDA drug approval package for Aliskiren hemifumarate

Abstract: Drug Approval Package documents downloaded from Drugs@FDA. Data extracted from various pdfs. - hERG study and start of ADME section: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021985s000_PharmR_P1.pdf - ADME/PK studies, metabolic schemes: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021985s000_PharmR_P2.pdf - Marmoset toxicity study including PK parameters: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021985s000_PharmR_P3.pdf - Metabolism studies and human PK: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021985s000_ClinPharmR_P1.pdf - human metabolic scheme: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021985s000_ClinPharmR_P2.pdf - human metabolic scheme: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021985s000_ClinPharmR_P3.pdf