Food Effect Study Design With Oral Drugs: Lessons Learned From Recently Approved Drugs in Oncology-Reference-Cited by-同舟云学术

Food Effect Study Design With Oral Drugs: Lessons Learned From Recently Approved Drugs in Oncology

Published:2018-12-10 Issue: Volume: Page:
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Farha Mark¹^ORCID,Masson Eric¹^ORCID,Tomkinson Helen²,Mugundu Ganesh¹^ORCID

Affiliation:

1. Quantitative Clinical PharmacologyEarly Clinical DevelopmentIMED Biotech UnitAstraZeneca Waltham MA USA

2. Quantitative Clinical PharmacologyEarly Clinical DevelopmentIMED Biotech UnitAstraZeneca Cambridge UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.1351

Reference45 articles.

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2. Food and Drug Administration.Clinical pharmacology 1: phase 1 studies and early drug development.https://www.fda.gov/downloads/training/clinicalinvestigatortrainingcourse/ucm340007.pdf. Accessed July 20 2018.

3. Effects of Food on the Clinical Pharmacokinetics of Anticancer Agents

4. Influence of Food Intake on Presystemic Clearance of Drugs

5. Food and Drug Administration.Food effect bioavailability and fed bioequivalence studies 2002.https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070241.pdf. Accessed July 21 2018.

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