Results 21 to 30 of about 1,299,629 (266)

International Approaches to Regulation of Medicinal Products Containing Viable Human Cells

Биопрепараты: Профилактика, диагностика, лечение, 2018
The intensive development of cellular technologies stipulates the introduction at the global level of medicinal products based on viable human cells, which in most countries are referred to as biomedical cell products. The authors conducted a comparative
E. V. Melnikova, A. A. Goryaev, M. V. Savkina, O. V. Merkulova, A. A. Chaplenko, O. A. Rachinskaya, I. S. Semenova, G. A. Trusov, V. A. Merkulov   +8 more
doaj   +1 more source

Evaluation of Cell Line Identity Using RTCA Profiling for Quality Control of Products Containing Viable Human Cells

Разработка и регистрация лекарственных средств, 2023
Introduction. Identity is an important quality attribute of products containing viable human cells, to be tested during the quality control. The verification of identity includes, among other things, determination of the proliferative activity of the ...
M. A. Vodyakova, O. A. Rachinskaya, N. S. Pokrovsky, I. S. Semenova, E. V. Melnikova, V. A. Merkulov   +5 more
doaj   +1 more source

Safety of Antibacterial and Antiprotozoal Medicinal Products

Безопасность и риск фармакотерапии, 2022
The experts of the Scientific Centre for Expert Evaluation of Medicinal Products analysed administrative decisions of foreign regulatory authorities on the recalls of antibacterial and antiprotozoal medicinal products and/or the need for labelling ...
E. V. Shubnikova, T. M. Bukatina, A. A. Druzhinina, E. O. Zhuravleva, G. V. Kutekhova, N. Yu. Velts   +5 more
doaj   +1 more source

A METHODOLOGICAL APPROACH TO DESIGNING EXPERIMENTS WHEN DEALING WITH IDENTIFICATION TESTS FOR MEDICINAL PRODUCT COMPONENTS (AS ILLUSTRATED BY ASCORBIC ACID)

Регуляторные исследования и экспертиза лекарственных средств, 2018
The need for identification  testing of active substances or excipients in multi-component medicinal products,  including the use of qualitative tests, calls for research substantiating the choice of tests and test conditions  with due regard to ...
Yu. B. Purim, M. L. Kruglyakova, L. N. Bulanova, M. V. Agapkina, L. N. Stronova, T. N. Bokovikova, E. P. Gernikova   +6 more
doaj   +1 more source

Challenges in development and authorisation of gene therapy products

Биопрепараты: Профилактика, диагностика, лечение, 2022
There are a lot of diseases known today, which are caused by genetic abnormalities. Advances in genetics and biotechnology brought about gene editing technologies that can produce almost any gene, which ultimately led to the emergence of a new class of ...
A. A. Soldatov, Zh. I. Avdeeva, D. V. Gorenkov, L. M. Khantimirova, S. G. Guseva, V. A. Merkulov   +5 more
doaj   +1 more source

Rational Use of Herbal Products in Pediatric Patients Treated With Anticancer Drugs in the European Union

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Introduction The use of herbal medical preparation (HMP) is rising among pediatric oncology patients, often to manage treatment‐related symptoms. Their effectiveness remains uncertain, and the risk of herb–drug interactions is underestimated.
Orianne Mahot, Mathieu Corvaisier, Laurence Spiesser‐Robelet, Mylène Duplan, Isabelle Pellier, Delphine Bourneau‐Martin, Séverine Derbré   +6 more
wiley   +1 more source

Personalized Zebrafish Models for Fusion‐Positive Pediatric Sarcomas

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Clinical sequencing efforts have revolutionized our approaches to categorizing pediatric cancers in real time. This has dramatically improved our ability to profile pediatric tumors, identify actionable vulnerabilities, and influence clinical care.
Lisa H. Hall, Emma N. Harrison, Genevieve C. Kendall   +2 more
wiley   +1 more source

Pharmacogenetic Approaches to Enhancing Efficacy and Safety of Statins as Illustrated by the Example of Atorvastatin

Безопасность и риск фармакотерапии, 2020
Statins are efficacious lipid-lowering drugs used for prevention of cardiovascular complications in patients with high blood cholesterol. The efficacy and safety of this group of drugs is largely determined by genetic factors. The aim of the study was to
R. Ye. Kazakov, O. A. Checha, I. A. Mazerkina, E. Yu. Demchenkova, T. A. Aleksandrova, V. A. Evteev, S. A. Belkov, A. B. Prokofiev   +7 more
doaj   +1 more source

Health Literacy, Self‐Efficacy and Knowledge of Sickle Cell Disease Among Caregivers

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background Sickle cell disease (SCD) is a hereditary blood disorder in which abnormal haemoglobin leads to severe anaemia, painful crises and organ failure. Caregivers’ health literacy (HL) – their ability to assess, understand and apply information, and interact with healthcare professionals – is crucial for managing children with SCD, yet ...
Melanie Bruinooge, Maite E. Houwing, Rowena L. Grohssteiner, Ferdows Atiq, Sonja A. M. C. Teuben, Mirjam P. Fransen, Marjon H. Cnossen   +6 more
wiley   +1 more source

METHODOLOGICAL APPROACHES TO EXPERT EVALUATION OF PRECLINICAL AND CLINICAL TRIALS OF HUMAN IMMUNOGLOBULIN PRODUCTS

Медицинская иммунология, 2017
The article considers the experience of Russian and leading foreign regulatory agencies in organisation and conduction of preclinical and clinical trials of human immunoglobulin products.
V. B. Ivanov, V. D. Mosyagin, E. Yu. Kudasheva, Yu. V. Olefir, V. A. Merkulov, I. V. Borisevitch, V. P. Bondarev   +6 more
doaj   +1 more source