Batch‐to‐Batch and Within‐Subject Variability: What Do We Know and How Do These Variabilities Affect Clinical Pharmacology and Bioequivalence?
- 16 January 2019
- journal article
- research article
- Published by Wiley in Clinical Pharmacology & Therapeutics
- Vol. 105 (2), 326-328
- https://doi.org/10.1002/cpt.1294
Abstract
No abstract availableKeywords
This publication has 4 references indexed in Scilit:
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- Between‐Batch Pharmacokinetic Variability Inflates Type I Error Rate in Conventional Bioequivalence Trials: A Randomized Advair Diskus Clinical TrialClinical Pharmacology & Therapeutics, 2016
- Batch‐to‐batch pharmacokinetic variability confounds current bioequivalence regulations: A dry powder inhaler randomized clinical trialClinical Pharmacology & Therapeutics, 2016
- Novel bioequivalence approach for narrow therapeutic index drugsClinical Pharmacology & Therapeutics, 2014