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The Regulation of Biological and other Innovative Medicinal Products

2021
Abstract This chapter discusses the phrase ‘biological medicinal product’, which is used to refer to products manufactured by biological or biotechnology means or to advanced therapy medicinal products. It examines biological medicinal products that are considered peptides or proteins and are made up of one or more linear sequences of ...
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Medicinal plant resin natural products: structural diversity and biological activities

Natural Product Reports
This review explores medicinal plant resin natural products from six genera, encompassing 1115 structures and their biological activities, offering insights into the chemical and biological profiling of plant resins produced under various stress.
Madhu Babu Sura, Yong-Xian Cheng
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Do Biological Medicinal Products Pose a Risk to the Environment?

Drug Safety, 2009
The occurrence of active pharmaceutical substances in the environment is of growing concern. The vast majority of the compounds in question are of low molecular weight, intended for oral use and designed to tolerate, for example, the digestive enzymes in the upper alimentary tract, the harsh milieus found in the acidic stomach, or the microbe rich ...
Thomas C, Kühler   +4 more
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[Approval of clinical trials with biological medicinal products].

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz, 2018
Biological medicinal products can be distinguished from chemically characterized medicines. Their active substance is either extracted or manufactured from organic source materials. Monoclonal antibodies are currently the fastest growing product class in the pharmaceutical sector.
Steffen, Gross   +2 more
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Microbial production of small medicinal molecules and biologics: From nature to synthetic pathways

Biotechnology Advances, 2018
Natural products are promising chemicals due to their structural diversity and bioactivities. Over the decades, a vast variety of gene clusters encoding natural products have been identified and overexpressed in microbes. Recently, the development of metabolic engineering, synthetic biology and bioinformatics strategies have facilitated target ...
Ruihua, Zhang   +4 more
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[Special considerations for the regulation of biological medicinal products in individualised medicine. More than stratified medicine].

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz, 2014
The term individualised medicine, also called personalised medicine, is commonly used as an equivalent to stratified medicine. However, this is erroneous since quite often it is forgotten that especially biological medicinal products have other aspects of individualization that go beyond mere stratification.
J, Müller-Berghaus   +3 more
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Introduction to the European medicinal law. Biological medicinal products

Remedium. Journal about the Russian market of medicines and medical equipment, 2013
A.N. Vasiliev   +4 more
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Natural products in drug discovery: advances and opportunities

Nature Reviews Drug Discovery, 2021
Atanas G Atanasov   +2 more
exaly  

Demystifying racemic natural products in the homochiral world

Nature Reviews Chemistry, 2022
Gabin T Mbahbou Bitchagno   +2 more
exaly  

REGULATORY ASPECTS OF REGISTRATION OF MEDICINAL PRODUCTS AND BIOLOGICALLY ACTIVE SUPPLEMENTS

"Medical & pharmaceutical journal "Pulse"
The pharmaceutical market has demonstrated significant growth rates for decades, one of the factors of which is the multiple increase in the range of biologically active additives. At the same time, segmentation of the pharmaceutical market into drugs and biologically active additives presupposes the presence of clear, unambiguous criteria that exist ...
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