Search results with tag "Carcinogenicity studies"
S 1 A The Need for Carcinogenicity Studies of …
www.ema.europa.eu© EMEA 2006 2 GUIDELINE ON THE NEED FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS 1. INTRODUCTION The objectives of carcinogenicity studies are to identify a tumorigenic potential in animals
S 3 A Toxicokinetics: A Guidance for Assessing Systemic ...
www.ema.europa.euToxicity studies which may be usefully supported by toxicokinetic information include single and repeated-dose toxicity studies, reproductive, genotoxicity and carcinogenicity studies. Toxicokinetic information may also be of value in assessing the implications of a proposed change in the clinical route of administration. 3.
HALDOL - Food and Drug Administration
www.accessdata.fda.govThe need for continued treatment should be reassessed periodically. ... Carcinogenicity studies using oral haloperidol were conducted in Wistar rats (dosed at up to 5 mg/kg daily for 24 months) and in Albino Swiss mice (dosed at up to 5 mg/kg daily for 18 months). In the rat study survival was less than optimal in all
DRAFT OECD GUIDELINE FOR THE TESTING OF …
www.oecd.org1 DRAFT OECD GUIDELINE FOR THE TESTING OF CHEMICALS Test Guideline 453: Combined Chronic Toxicity\Carcinogenicity Studies INTRODUCTION 1. OECD Guidelines for the Testing of Chemicals are periodically reviewed in the light of
DRAFT OECD GUIDELINE FOR THE TESTING OF …
www.oecd.orgDraft Consultant Proposal v. 6 OECD TG 451 November 2008 1 DRAFT OECD GUIDELINE FOR THE TESTING OF CHEMICALS Test Guideline 451: Carcinogenicity Studies
BATCH Q: Quality - International Council for …
www.ich.orgICH Guidelines Index BATCH S: Safety Finalised Guidelines (Step 4) S1A Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals Nov. 1995