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Levothyroxine Bioequivalence Study and Its Narrow Therapeutic Index: Comparative Bioavailability Results Between Two Formulations Available in Latin America.
Adv Ther
April 2023
Scientific Medical Direction, Tecnoquímicas, Cali, Colombia.
Introduction: The history of levothyroxine has been linked to advances in the treatment of thyroid disease and to date it is the standard therapy for the treatment of hypothyroidism. Bioequivalence studies are the most widely used method to demonstrate interchangeability, although controversy persists regarding the best design for this molecule declared as a narrow therapeutic index product in many countries. This study aimed to evaluate the pharmacokinetic profile of two formulations of levothyroxine to determine bioequivalence between them.
View Article and Find Full Text PDFPharmacokinetic Interaction between Atorvastatin and Omega-3 Fatty Acid in Healthy Volunteers.
Pharmaceuticals (Basel)
August 2022
Chungnam National University Hospital Clinical Trials Center, Daejeon 35015, Korea.
Article Synopsis
- The study aimed to explore how atorvastatin (a statin) and omega-3 fatty acids interact at a pharmacokinetic level through a phase 1 trial.
- Researchers conducted the trial with 37 subjects who were administered different combinations of atorvastatin and omega-3 over specified periods to measure drug concentrations.
- Results showed significant pharmacokinetic interactions between atorvastatin and omega-3 fatty acids, as highlighted by the geometric mean ratios and 90% confidence intervals indicating deviations from typical bioequivalence standards.
Investigation of the discriminatory ability of analytes for the bioequivalence assessment of ezetimibe: Parent drug, metabolite, total form, and combination of parent drug and total form.
Eur J Pharm Sci
July 2022
Faculty of Pharmacy, National Yang Ming Chiao Tung University, Taipei, Taiwan; Center of Consultation, Center for Drug Evaluation (CDE), Taipei, Taiwan. Electronic address:
The analysis of parent drug is usually the design of choice for a bioequivalence (BE) study. However, there is a controversy regarding the choice of analytes between EMA and USFDA for the BE study of ezetimibe (EZE). The EMA recommends measuring the total form alone, that means the sum of the concentration of "parent" EZE and "metabolite" ezetimibe-glucuronide (EZEG), as the BE determination.
View Article and Find Full Text PDFLack of Evidence for Blood Pressure Effects of Caffeine Added to Ibuprofen.
Curr Drug Saf
February 2023
CHC Medical Affairs, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.
Background: Caffeine enhances the efficacy of non-opioid analgesics. Data on the cardiovascular health effects of caffeine intake are controversial, and studies on the cardiovascular effects of medical caffeine use are lacking.
Objective: The study aims to explore the cardiovascular effects of an ibuprofen/caffeine combination in comparison to ibuprofen alone.
Narrow Therapeutic Index drugs: clinical pharmacology perspective.
J Pharm Pharmacol
September 2021
Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, MD, USA.
Objectives: Historically, the identification of drugs with the Narrow Therapeutic Index (NTI) has been empirically based on the clinical practice. In general terms, NTI drugs can be defined based on the steepness of the dose-response relationship and the degree of overlap between the effective and the toxic concentrations.
Key Findings: The current definition in the Code of Federal Regulations is based on animal data and as such lacks direct clinical relevance.
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