Results 11 to 20 of about 116,480 (161)

Modern biological/biotechnological medicinal products. Topical issues and prospects for development

Биопрепараты: Профилактика, диагностика, лечение, 2018
The review provides with the information, related to the development, research and registration of new biological preparations, including the issues of terminology and classification.
Yu. V. Olefir, N. V. Medunitsyn, Zh. I. Avdeeva, A. A. Soldatov, A. A. Movsesyants, V. A. Merkulov, V. P. Bondarev   +6 more
doaj   +1 more source

Comparative Physicochemical and Biological Characterisation of the Similar Biological Medicinal Product Teriparatide and Its Reference Medicinal Product [PDF]

BioDrugs, 2019
In January 2017, the European Commission approved Terrosa® (company code RGB-10) as one of the first biosimilar medicinal products of teriparatide for the same indications as for the reference medicinal product Forsteo® (Lilly France S.A.S.), which has been on the market in the European Union since 2003.
Piroska Kovács, Tamás Schäfer, Viktor Háda, Helga Hevér, Sonja Klingelhöfer, Merle Nebel, Tanja Stadie, Róbert Kiss, Zoltán Urbányi   +8 more
openaire   +2 more sources

Implementation of Plasma Fractionation in Biological Medicines Production [PDF]

Iranian Journal of Biotechnology, 2016
The major motivation for the preparation of the plasma derived biological medicine was the treatment of casualties from the Second World War. Due to the high expenses for preparation of plasma derived products, achievement of self-sufficiency in human plasma biotechnological industry is an important goal for developing countries.The complexity of the ...
Mousavi Hosseini, Kamran, Ghasemzadeh, Mehran   +1 more
openaire   +2 more sources

Biosimilars, the journey has begun [PDF]

Farmacia Hospitalaria, 2015
According to the European Medicine Agency, a “biosimilar” is a biological medicinal product that contains a version of the active substance of an original biological medicinal product (reference or innovative medicinal product) that has been authorized ...
Alba Martos-Rosa, Juan Enrique Martínez-de la Plata, Jose Antonio Morales-Molina, Anna Fayet- Pérez, Pedro José Acosta-Robles   +4 more
doaj   +1 more source

PENANGANAN DAN PENERAPAN TEKNOLOGI PASCAPANEN TANAMAN OBAT

Agrointek, 2021
Post-harvest handling of medicinal plants (MP) is an important process for providing medicinal materials which either directly used as a simplicia or further processed products.
Harto Widodo, Dyah Subositi
doaj   +1 more source

Emerging Insights into European Markets of Biologics, Including Biosimilars

Pharmaceuticals, 2022
Biological medicinal products have revolutionised the treatment of many diseases, e [...]
Steven Simoens, Isabelle Huys
doaj   +1 more source

RNA-based drugs and regulation: Toward a necessary evolution of the definitions issued from the European union legislation

Frontiers in Medicine, 2022
Many RNA-based drugs, both vaccines and non-vaccines, are under development or even approved. They include coding mRNAs and non-coding (nc) RNAs among them antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), micro-RNAs (miRNAs), small ...
Mathieu Guerriaud, Evelyne Kohli
doaj   +1 more source

Approaches to Pharmaceutical Analysis of Modern Peptide and Oligonucleotide Products as Illustrated by a Small Interfering RNA-Based Novel Therapeutic for the Treatment of Bronchial Asthma

Биопрепараты: Профилактика, диагностика, лечение, 2018
Methods used to control the quality of peptide products depend on the level of development of analytical and bioorganic chemistry, and the level of instrumentation.
L. M. Krasnykh, V. V. Smirnov, G. V. Ramenskaya, G. F. Vasilenko, I. P. Shilovsky, M. R. Haitov   +5 more
doaj   +1 more source

ECDC, EFSA and EMA Joint Scientific Opinion on a list of outcome indicators as regards surveillance of antimicrobial resistance and antimicrobial consumption in humans and food‐producing animals

EFSA Journal, 2017
ECDC, EFSA and EMA have jointly established a list of harmonised outcome indicators to assist EU Member States in assessing their progress in reducing the use of antimicrobials and antimicrobial resistance (AMR) in both humans and food‐producing animals.
ECDC, EFSA Panel on Biological Hazards (BIOHAZ), EMA Committee for Medicinal Products for Veterinary Use (CVMP)   +1 more
doaj   +1 more source

Biological, biotechnological and biosimilar medicinal products

Annual for Hospital Pharmacy, 2017
Настоящата публикация изяснява основните термини, касаещи биологичните и биотехнологични лекарствени продукти, както и популярната напоследък тема за употребата на биоподобни лекарства. Представени са основните характеристики на биологичните лекарства, приложението на биотехнологичните методи за производство на лекарства, както и концепцията за ...
A. Stoimenova, L. Antonov
openaire   +2 more sources