Product Equivalence Study Comparing the Tolerability, Pharmacokinetics, and Pharmacodynamics of Various Human Immunoglobulin‐G Formulations
- 1 July 2000
- journal article
- clinical trial
- Published by Wiley in The Journal of Clinical Pharmacology
- Vol. 40 (7) , 722-730
- https://doi.org/10.1177/00912700022009477
Abstract
In this randomized, double‐blind, parallel‐group study, a commercially available human immunoglobulin‐G product, IVIG, was compared with two test formulations: (1) IVIG‐N, which is a nanofiltered for...Keywords
This publication has 10 references indexed in Scilit:
- Transmission Rates of Hepatitis C Virus by Different Batches of a Contaminated Anti‐D Immunoglobulin PreparationVox Sanguinis, 1999
- Evaluation of truncated areas in the assessment of bioequivalence of immediate release formulations of drugs with long half-lives and of Cmax with different dissolution rates.Pharmaceutical Research, 1999
- Mechanisms of action of intravenous immune serum globulin in autoimmune and inflammatory diseases.Journal of Allergy and Clinical Immunology, 1997
- USE OF INTRAVENOUS IMMUNOGLOBULIN TO PREVENT OR TREAT INFECTIONS IN PERSONS WITH IMMUNE DEFICIENCYAnnual Review of Medicine, 1997
- Clinical and Virologic Features of Hepatitis C Virus Infection Associated With Intravenous ImmunoglobulinPediatrics, 1996
- An Outbreak of Acute Hepatitis C Among Recipients of Intravenous ImmunoglobulinAnnals of Allergy, Asthma & Immunology, 1996
- Nicotinamide pharmacokinetics in humans and mice: a comparative assessment and the implications for radiotherapyRadiotherapy and Oncology, 1993
- High-performance liquid chromatographic determination of nicotinamide and its metabolites in human and murine plasma and urineJournal of Chromatography B: Biomedical Sciences and Applications, 1992
- Intravenous ImmunoglobulinJAMA, 1990
- A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailabilityJournal of Pharmacokinetics and Biopharmaceutics, 1987