Batch-to-Batch and Within-Subject Variability: What Do We Know and How Do These Variabilities Affect Clinical Pharmacology and Bioequivalence?

Clin Pharmacol Ther. 2019 Feb;105(2):326-328. doi: 10.1002/cpt.1294. Epub 2019 Jan 16.

Authors

Leslie Z Benet¹, Priya Jayachandran¹, Kevin J Carroll², Elise Burmeister Getz³

Affiliations

¹ Department of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California San Francisco, San Francisco, California, USA.
² KJC Statistics, Bramhall, Cheshire, UK.
³ Oriel Therapeutics, Inc., Emeryville, California, USA.

PMID: 30652313
DOI: 10.1002/cpt.1294

No abstract available

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Administration, Inhalation
Anticoagulants / pharmacokinetics
Anticoagulants / standards
Chemistry, Pharmaceutical / standards
Cross-Over Studies
Drugs, Generic / adverse effects
Drugs, Generic / standards*
Drugs, Generic / therapeutic use
Dry Powder Inhalers / standards
Humans
Legislation, Drug
Pharmacology, Clinical*
Reproducibility of Results
Therapeutic Equivalency*
Warfarin / pharmacokinetics
Warfarin / standards

Substances

Anticoagulants
Drugs, Generic
Warfarin