Human anti-D immunoglobulin preparations: potency standardisation milestones

Human anti-D immunoglobulin preparations: potency standardisation milestones

Human anti-D immunoglobulin preparations derived from human immune plasma are much needed and highly effective for specific anti-D prevention of perinatal complications and treatment of primary immune thrombocytopenia. The effectiveness of immune suppression is a direct function of the active ingred...

Full description

Saved in:

Bibliographic Details
Main Authors:	N. S. Vildanova, E. S. Kormshchikova, E. N. Kalinina, K. A. Vorobiev, I. V. Paramonov, E. Yu. Kudasheva
Format:	Article
Language:	Russian
Published:	Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2022-10-01
Series:	Биопрепараты: Профилактика, диагностика, лечение
Subjects:	human anti-d immunoglobulin potency reference standard international standard reference standard development and certification
Online Access:	https://www.biopreparations.ru/jour/article/view/410
Tags:	Add Tag No Tags, Be the first to tag this record!

Similar Items

Certification of a pharmacopoeial reference standard for potency testing of recombinant interferon α-2b
by: L. A. Gaiderova, et al.
Published: (2024-03-01)

Requirements for the information on reference standards submitted in the dossier for biologicals
by: R. A. Volkova, et al.
Published: (2024-03-01)

Determination of quality criteria for candidate standard for anti-D immunoglobulin
by: E. N. Kalinina, et al.
Published: (2024-01-01)

Recommendations on the certification of reference standards for structure identification of recombinant therapeutic proteins
by: O. B. Ustinnikova, et al.
Published: (2022-07-01)

Expert panel as reference standard procedure in diagnostic accuracy studies: a systematic scoping review and methodological guidance
by: Bas E. Kellerhuis, et al.
Published: (2025-05-01)

Contemplation of the possibility of extending the shelf life of human immunoglobulin reference standard used for determination of anticomplementary activity
by: O. G. Kornilova, et al.
Published: (2018-02-01)

Potency evaluation of erythropoietin products: current status
by: L. A. Gaiderova, et al.
Published: (2024-12-01)

Apprentissage de la conduite et sécurité routière
by: Bernard Prot
Published: (2011-10-01)

Radiation protection and quality control in radiography services: a comparative study between national and international standards
by: Alex Oliveira, et al.
Published: (2025-04-01)

Development of a Procedure for the Identification of Pharmaceutical Substance «Buserelin Acetate» by NMR Spectroscopy without Using Pharmacopoeia Reference Standard
by: N. E. Kuzmina, et al.
Published: (2020-05-01)

Physical Fitness Benchmarks for Preschool Children in South Korea: A Population-Based Study
by: Moon-Yeon Oh, et al.
Published: (2025-03-01)

Development Status and Future Prospects of Reference Materials for the Leather and Footwear Industry in China
by: Jiyu LIANG, et al.
Published: (2025-08-01)

Establishing a new human pneumococcal standard reference serum, MPRSS-01
by: Joseph M. Antonello, et al.
Published: (2025-01-01)

CERTIFICATION - THE ACTIVITY WHICH INFLUENCES THE DEVELOPMENT LEVEL OF HUMAN SOCIETY
by: Constanta RADULESCU, et al.
Published: (2013-05-01)

Prediction of spirometry parameters using chest circumference in Sri Lankan boys aged 8-16 years
by: Guwani Liyanage, et al.
Published: (2017-11-01)

Intervenir avec des masseurs-kinésithérapeutes : le développement en référence
by: Stéphane Balas
Published: (2013-04-01)

THE ROLE OF REFERENCE STANDARDS IN QUALITY ASSURANCE FOR MEDICINES: REGULATORY AND METROLOGICAL ASPECTS
by: D. A. Leontiev, et al.
Published: (2019-01-01)

Relevant Issues of Standardisation of Herbal Drugs and Herbal Drug Preparations Containing Essential Oils
by: T. K. Ryazanova, et al.
Published: (2023-06-01)

TRENDS IN FIELD OF REFERENCE MATERIALS IN RUSSIA
by: E. V. Osintseva, et al.
Published: (2017-05-01)

Research on big data platform architecture and standardization for specific fields
by: Wangqun LIN, et al.
Published: (2017-07-01)

Fetal growth in Bogotá, Colombia: a comparison with international and latin american curves
by: Gabriela Marisol Vallejo, et al.
Published: (2024-11-01)

Participation of VNIIFTRI in international comparisons in thefield of physical-chemical measurements
by: V. I. Dobrovolskiy, et al.
Published: (2019-02-01)

The system of secondary reference standards in drug quality control laboratories
by: D. A. Leontiev
Published: (2018-02-01)

Harmonisation of Russian and Foreign Pharmacopoeial Standard Terms
by: Z. S. Shprakh
Published: (2020-09-01)

Legal aspects of functional security standardisation of the Internet of Things
by: P. S. Klimushyn, et al.
Published: (2023-09-01)

The problem of improving the quality of seriously issued certified reference materials of the composition of gas mixtures
by: L. A. Konopelko, et al.
Published: (2019-11-01)

Engineers and masters education on metrology, standardization and certifications
by: Е. G. Khomutova, et al.
Published: (2010-02-01)

NMR as Used in the Russian and Foreign Pharmacopoeias for Quality Control of Medicinal Products
by: S. V. Moiseev, et al.
Published: (2022-04-01)

Improvement of the Russian National Secondary Standard of the Unit of Length Using Latest Ultra-Stable Laser Equipment
by: Andrew A. Mosckalev, et al.
Published: (2019-10-01)

Variability in interpretation of static renal scintigraphy findings
by: Jakšić Emilija, et al.
Published: (2005-01-01)

Examining the Effects of Different Exertion Levels and Reference Standards on the Diagnostic Accuracy of Exercise ECG for Detecting Coronary Artery Disease — A Pilot Study
by: Julius Heimann, et al.
Published: (2025-01-01)

Assessment of the safety of priority carcinogenic substances at the level of hygienic regulations in atmospheric air
by: I.O. Chernychenko, et al.
Published: (2023-06-01)

The first WHO reference panel for Infliximab anti-drug antibodies: a step towards harmonizing therapeutic drug monitoring
by: Meenu Wadhwa, et al.
Published: (2025-03-01)

Problematic aspects of IoT cybersecurity standardisation
by: P. S. Klimushyn
Published: (2025-04-01)

Development of recombinant adeno-associated virus empty capsids as a reference standard for quality control of gene therapy products
by: A. V. Tumaev, et al.
Published: (2024-07-01)

A novel proof of concept approach towards generating reference microplastic particles
by: Simon D.J. Oster, et al.
Published: (2024-12-01)

The Acquiring of the Knowledge about Standards in the Digital Era
by: Ivana Mijatović, et al.
Published: (2019-05-01)

DEVELOPMENT OF QUALITY CONTROL SAMPLE TO ASSESS SPECIFIC ACTIVITY OF ANTI-RABIES IMMUNOGLOBULIN OBTAINED FROM EQUINE BLOOD SERUM
by: E. G. Abramova, et al.
Published: (2019-01-01)

Detecting Schistosoma infections in endemic countries: a diagnostic accuracy study in rural Madagascar
by: Eva Lorenz, et al.
Published: (2025-03-01)

The Science Behind Nefertiti's Beauty: A Plastic Surgeon's Analysis
by: Neha Chauhan
Published: (2022-12-01)