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On the interchangeability of biologic drug products

Statistics in Medicine, 2012
Interchangeability of drug products has very different features with small molecules and with biologicals. With small‐molecule drugs, a statement of bioequivalence generally indicates therapeutic equivalence and interchangeability. In contrast, with the much more sensitive and complicated biological drugs, a declaration of biosimilarity emphatically ...
Endrenyi L   +3 more
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The Gastrins: Their Production and Biological Activities

Annual Review of Physiology, 2001
▪ Abstract  Gastric epithelial organization and function are controlled and maintained by a variety of endocrine and paracrine mediators. Peptides encoded by the gastrin gene are an important part of this system because targeted deletion of the gene, or of the gastrin-CCKB receptor gene, leads to decreased numbers of parietal cells and decreased ...
G J, Dockray   +3 more
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Biological production of 2,3-butanediol

Applied Microbiology and Biotechnology, 2001
2,3-Butanediol (2,3-BDL), which is very important for a variety of chemical feedstocks and liquid fuels, can be derived from the bioconversion of natural resources. One of its well known applications is the formation of methyl ethyl ketone, by dehydration, which can be used as a liquid fuel additive. This article briefly reviews the basic properties of
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Biological production of 5-methylthioribose

Canadian Journal of Microbiology, 1973
Production of methylthioribose by Escherichia coli was investigated under various growth conditions using sulfate as the exogenous source of sulfur. Methylthioribose was shown by tracer and chromatographic methods to be a normal biosynthetic product secreted into the medium and accumulated there.
H R, Schroeder   +3 more
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What Are Biologics, Biological Products and Biological Drugs?

2014
Following the deaths of 14 children from contaminated antitoxins and smallpox vaccines, Congress in 1902 passed the Biologics Control Act, which is also known as The Virus-Toxin Law. This act required manufacturers to be licensed for safety and was a precursor and model for the Food Drugs and Cosmetics Act of 1938 which also emphasized safety.
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Hydrogenases for biological hydrogen production

Bioresource Technology, 2011
Biological H2 production offers distinctive advantages for environmental protection over existing physico-chemical methods. This study focuses specifically on hydrogenases, a class of enzymes that serves to effectively catalyze H2 formation from protons or oxidation to protons.
Dong-Hoon, Kim, Mi-Sun, Kim
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Osmoregulation and Biological Energy Production

1980
The interests of the Department of Energy (DOE) in osmoregulation research are fairly straightforward. As you are all aware, there is much being made these days about the importance of biomass and how biomass can serve as an alternate to fossil fuels. Many of these claims are highly optimistic while others tend to minimize the contribution that biomass
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Biological Processes for Hydrogen Production

2016
Methane is produced usually from organic waste in a straightforward anaerobic digestion process. However, hydrogen production is technically more challenging as more stages are needed to convert all biomass to hydrogen because of thermodynamic constraints.
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BIOLOGICAL PRODUCTS

Canadian Medical Association journal, 2010
ADAMS RALPH   +2 more
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