Results 41 to 50 of about 1,606 (135)

Safety and efficacy of a feed additive consisting of vitamin B12 (cyanocobalamin) produced by fermentation with Ensifer adhaerens CCTCC M 20241585 for all animal species (Orffa Additives B.V.)

EFSA Journal, Volume 24, Issue 4, April 2026.
Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of vitamin B12 (cyanocobalamin) produced by fermentation with Ensifer adhaerens CCTCC M 20241585, when used as a nutritional additive for all animal species.
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López‐Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto‐Maradona, Katerina Theodoridou, Pier Sandro Cocconcelli, Elisa Pettenati, Jaume Galobart, Maria Vittoria Vettori, Piera Valeri   +20 more
wiley   +1 more source

Artemisinin‐Based Combination Therapies in East Africa: A Systematic Review of Quality, Clinical Efficacy, and Regulatory Progress Towards Sustainable Malaria Control

Tropical Medicine &International Health, Volume 31, Issue 3, Page 254-273, March 2026.
ABSTRACT Background Malaria is a major public health issue in East Africa, leading to widespread illness and fatalities, especially among vulnerable populations such as children under 5 years of age and pregnant women. Artemisinin‐based combination therapies (ACTs) are the primary treatment modality; however, their efficacy is undermined by the ...
Yesuneh Tefera Mekasha, Addisu Afrassa Tegegne, Tapfumanei Mashe, Million Girma, Gemmechu Hasen, Sileshi Belew   +5 more
wiley   +1 more source

Identifying Histamine Impurity in Biological Products: Prospective Transition from in vivo to in vitro Methods

Регуляторные исследования и экспертиза лекарственных средств
INTRODUCTION. Drug impurities lowering blood pressure can cause side effects in patients. These impurities include histamine and other depressor substances.
E. A. Smiryagin, O. G. Kornilova, V. L. Bagirova   +2 more
doaj   +1 more source

Modern approaches to drafting general and individual monographs on human blood products

Регуляторные исследования и экспертиза лекарственных средств, 2018
Blood products were first represented in the State Pharmacopoeia of the USSR IX and X editions (1961 and 1968) by a single monograph "Gamma globulin for the prevention of measles".
A. V. Karyakin, T. M. Kargina, E. I. Sakanyan, I. G. Osipova, A. A. Movsesyants, E. Y. Kudasheva   +5 more
doaj  

Microbial Quality of Dehydrated Media Used in the Sterility Testing of Immunobiological Medicinal Products

Биопрепараты: Профилактика, диагностика, лечение, 2018
Medicinal products fail sterility testing if visual observation shows the growth of microorganisms that manifests itself as turbidity, sedimentation, flocculation and other changes in the growth medium.
S. M. Sukhanova, N. E. Zakharova
doaj   +1 more source

New opportunities for the determination of active substances in organic compounds

Регуляторные исследования и экспертиза лекарственных средств, 2018
The general monograph developed for the Russian State Pharmacopoeia describes the opportunity for using special equipment called «elemental analyzer» to solve the problem of determining active ingredients in pharmaceuticals by determining the elements C,
L. I. Mitkina
doaj  

Re‐evaluation of sucralose (E 955) as a food additive and evaluation of a new application on extension of use of sucralose (E 955) in fine bakery wares

EFSA Journal, Volume 24, Issue 2, February 2026.
Abstract The present opinion deals with the re‐evaluation of sucralose (E 955) as food additive and with the safety of a proposed extension of use in food category (FC) 7.2 ‘Fine bakery wares’. Based on the available data, no safety concerns arose for genotoxicity of sucralose (E 955) and its impurities and degradation products.
EFSA Panel on Food Additives and Flavourings (FAF), Laurence Castle, Monica Andreassen, Gabriele Aquilina, Maria Lourdes Bastos, Polly Boon, Biagio Fallico, Rex FitzGerald, Maria Jose Frutos Fernandez, Bettina Grasl‐Kraupp, Ursula Gundert‐Remy, Rainer Gürtler, Eric Houdeau, Marcin Kurek, Henriqueta Louro, Patricia Morales, Sabina Passamonti, Monika Batke, Antonios Douros, James Chipman, Riccardo Crebelli, Peter Fürst, Thorhallur Halldorsson, Manuela Mirat, Alicja Mortensen, Matthew Wright, Oliver Lindtner, Stefania Barmaz, Consuelo Civitella, Zsuzsanna Horvath, Sara Levorato, Elena Mazzoli, Josef Daniel Rasinger, Ana Maria Rincon, Camilla Smeraldi, Alexandra Tard, Federica Lodi   +36 more
wiley   +1 more source

Elemental Impurities in Gelatine Capsules: Human Health Risk Assessment

Безопасность и риск фармакотерапии
INTRODUCTION. This work continues the authors’ earlier study on gelatine capsule contamination with elemental impurities, which resulted in proposing a list of elements for standardisation. To ensure the safe use of medicinal products in this dosage form,
V. M. Schukin, N. E. Kuz'mina, O. A. Matveeva, Yu. N. Shvetsova, E. S. Zhigilei   +4 more
doaj   +1 more source

Evaluation of the Stability of Performance of the Analytical Test Method Used for Determination of Anticomplementary Activity of Human Immunoglobulin Preparations

Биопрепараты: Профилактика, диагностика, лечение, 2019
The evaluation of anticomplementary activity, being an obligatory component of the quality control ofhuman immunoglobulin preparations, requires the use of a number of reagents of biological origin that are difficult to standardise.
O. G. Kornilova, E. A. Khusnatdinova, E. S. Konovalova, R. A. Volkova   +3 more
doaj   +1 more source

Ethnomedicinal Practices of the Fabaceae Family in Tanzania: A Systematic Review

The Scientific World Journal, Volume 2026, Issue 1, 2026.
This study is aimed at reviewing the ethnomedicinal, phytochemical and pharmacological properties of Fabaceae species used as sources of traditional medications in Tanzania. Using the Systematic Reviews and Meta‐Analyses (PRISMA) methodology, a comprehensive review was conducted on Fabaceae species used by Tanzanians through electronic databases such ...
David Sylvester Kacholi, Kalyani Sen
wiley   +1 more source