Results 51 to 60 of about 116,480 (161)

Biological and biosimilar medicinal products: safety and efficacy

, 2016
Biological medicinal products are one of most innovative and promising methods of pharmacotherapy. During the last 20 years several original biological medicinal products have been registered and marketed. Their safety and efficacy have been investigated thoroughly at the level of pre-clinical and clinical studies.
openaire   +1 more source

Application of therapeutic nucleic acids and RNA interference to create products for personalised medicine

Биопрепараты: Профилактика, диагностика, лечение
INTRODUCTION. Small interfering RNAs (siRNAs) are among the most promising types of therapeutic nucleic acids aiming at the inhibition of pathogenetically relevant gene expression through the RNA interference mechanism.
I. P. Shilovskiy, G. B. Pasikhov, V. V. Smirnov, I. A. Kofiadi, M. V. Popova, P. A. Strueva, M. R. Khaitov   +6 more
doaj   +1 more source

Reproducibility of GMP-compliant production of therapeutic stressed peripheral blood mononuclear cell-derived secretomes, a novel class of biological medicinal products. [PDF]

Stem Cell Res Ther, 2020
Laggner M, Gugerell A, Bachmann C, Hofbauer H, Vorstandlechner V, Seibold M, Gouya Lechner G, Peterbauer A, Madlener S, Demyanets S, Sorgenfrey D, Ostler T, Erb M, Mildner M, Ankersmit HJ.   +14 more
europepmc   +1 more source

First Generic Teriparatide: Structural and Biological Sameness to Its Reference Medicinal Product

Pharmaceutics
Teriparatide is an anabolic peptide drug indicated for the treatment of osteoporosis. Recombinant teriparatide was first approved in 2002 and has since been followed by patent-free alternatives under biosimilar or hybrid regulatory application. The aim of this study is to demonstrate the essential similarity between synthetic teriparatide BGW and the ...
Jimena Fernández-Carneado, Mariona Vallès-Miret, Sílvia Arrastia-Casado, Ana Almazán-Moga, Maria J. Macias, Pau Martin-Malpartida, Marta Vilaseca, Mireia Díaz-Lobo, Mayte Vazquez, Rosa M. Sanahuja, Gemma Gambús, Berta Ponsati   +11 more
openaire   +3 more sources

UE organisms for the reglementation and market’s maintenance of veterinary use products [PDF]

Medicamentul Veterinar, 2009
Following the Romania's EU accession in 2007, national legislation licensing, distribution and circulation of veterinary medicinal products has been harmonized with relevant Community legislation, namely Directive 2001/82 amended by Directive 2004/28 and
Lolita Taban,, Iuliana Moloiu
doaj  

Current Advances in the Functional Genes of Edible and Medicinal Fungi: Research Techniques, Functional Analysis, and Prospects

Journal of Fungi
Functional genes encode various biological functions required for the life activities of organisms. By analyzing the functional genes of edible and medicinal fungi, varieties of edible and medicinal fungi can be improved to enhance their agronomic traits,
Wenyun Li, Gen Zou, Dapeng Bao, Yingying Wu   +3 more
doaj   +1 more source

Current regulatory requirements for stability studies of biological medicinal products: a review

Биопрепараты: Профилактика, диагностика, лечение
INTRODUCTION. The stability assessment of biological medicinal products (BMPs) requires special approaches and regulatory requirements. Therefore, BMPs require relevant national guidelines, which are an important prerequisite for the assurance of the ...
A. A. Soldatov, A. K. Yakovlev, Zh. I. Avdeeva, D. V. Gorenkov, A. S. Korovkin, V. V. Kosenko   +5 more
doaj   +1 more source

Engineering the plant factory for the production of biologics and small-molecule medicines

, 2017
Plant gene transfer achieved in the early ‘80s paved the way for the exploitation of the potential of gene engineering to add novel agronomic traits and/or to design plants as factories for high added value molecules. For this latter area of research, the term "Molecular Farming” was coined in reference to agricultural applications in that major crops ...
MARTINIS, DOMENICO DE, Franconi, Rosella, Benvenuto, Eugenio, Fujiyama, Kazuhito, Rybicki, Ed   +4 more
openaire   +2 more sources

Pharmacopoeial standardisation of biological medicinal products: Basic principles for the common pharmaceutical market of the Eurasian Economic Union

Биопрепараты: Профилактика, диагностика, лечение
INTRODUCTION. The advancement of manufacturing technologies and the expanding range of biological medicinal products (BMPs) and indications for their use necessitate the development of a unified approach to BMP standardisation at both national and ...
O. G. Kornilova, V. L. Bagirova
doaj   +1 more source

Artificial intelligence in the discovery and modification of biological elements in medicinal plants

Medicinal Plant Biology
Active ingredients extracted from medicinal plants are important natural sources in the field of pharmaceutical and industrial products. However, the low abundance and quality of these compounds have consistently posed a significant barrier to the full ...
Jing Zhang, Yixin Yang, Jinping Si, Donghong Chen, Chuan Dong, Zhigang Han   +5 more
doaj   +1 more source