This paper proposes a sufficient bootstrap method, which uses only the unique observations in the resamples, to assess the individual bioequivalence under 2 × 4 randomized crossover design. The finite sample performance of the proposed method is illustrated by extensive Monte Carlo simulations as well as a real-experimental data set, and the results are compared with those obtained by the traditional bootstrap technique. Our records reveal that the proposed method is a good competitor or even better than the classical percentile bootstrap confidence limits.
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http://dx.doi.org/10.1002/pst.1930 | DOI Listing |
Drug Metab Dispos
January 2025
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
Evidence-based dose selection of drugs in pregnant women has been lacking because of challenges in studying maternal-fetal pharmacokinetics. Hence, many drugs are administered off-label during pregnancy based on data obtained from nonpregnant women. During pregnancy, drug transporters play an important role in drug disposition along with known gestational age-dependent changes in physiology and drug-metabolizing enzymes.
View Article and Find Full Text PDFJ Cancer Res Clin Oncol
January 2025
Phase I Clinical Trial Centre, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Purpose: The primary objectives of this trial were aimed at exploring the pharmacokinetic profiles and the human bioequivalence of an intravenous liposomal injection of doxorubicin hydrochloride in comparison with a reference formulation in Chinese patients diagnosed with metastatic breast cancer.
Methods: To achieve these goals, the trial employed a randomized, open-label, two-formulation crossover dosing strategy among Chinese patients with metastatic breast cancer. Pharmacokinetic (PK) evaluation was conducted through the collection of blood samples, and the liquid chromatography tandem mass spectrometry (LC/MS/MS) method was leveraged to quantify plasma concentrations of both liposome-encapsulated doxorubicin and non-encapsulated doxorubicin in patients.
Naunyn Schmiedebergs Arch Pharmacol
January 2025
Anhui Provincial Center of Drug Clinical Evaluation, Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, People's Republic of China.
Topiramate is an antiepileptic drug (AED) that is effective in treating various types of epilepsy. This study evaluated the bioequivalence and safety of two topiramate tablets in healthy Chinese subjects under fasting and fed conditions. We designed an open-label, randomized, single-dose, two-period, crossover trial protocol.
View Article and Find Full Text PDFDrug Deliv Transl Res
January 2025
Xiangya School of Pharmaceutical Sciences, Central South University, Changsha, 410006, Hunan, China.
Dapoxetine hydrochloride tablets are the most commonly used drug for the treatment of premature ejaculation (PE). However, the tablets must be taken with water 1-3 h before sexual activity, which makes the medication intake conspicuous and inconvenient. This study aimed to develop taste-masked orodispersible films (ODFs) of dapoxetine hydrochloride using ion exchange resins.
View Article and Find Full Text PDFInt J Pharm
January 2025
University of Tuebingen, Pharmaceutical Technology, Auf Der Morgenstelle 8 72076 Tuebingen, Germany. Electronic address:
Bioequivalence studies of topical formulations have attracted increased interest as the European Medicines Agencies "Guideline on quality and equivalence on locally applied, locally acting cutaneous products" describes them in the context of the approval of generics. Since the guideline only proposes tape stripping as a destructive method for bioequivalence testing in in vitro skin penetration, the aim of this study was to investigate the suitability of confocal Raman spectroscopy (CRS) as a non-destructive alternative. To validate the CRS results, tape stripping and CRS experiments using ketoprofen as a model API were performed consecutively on the same samples of ex vivo porcine skin after frozen storage and compared.
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