نتایج جستجو برای: biological products
تعداد نتایج: 736973 فیلتر نتایج به سال:
Many biologic products have improved the outcomes of cancer patients, but the costs can substantially burden healthcare systems. Biosimilar products can potentially reduce drug costs and increase patient access to beneficial treatments. Approval of a biosimilar product relies on the demonstration of "comparability" or "no clinically meaningful differences" as compared to its reference biologic ...
BACKGROUND The Biologics Price Competition and Innovation Act, introduced as part of the Affordable Care Act, directed the FDA to create an approval pathway for biologic products shown to be biosimilar or interchangeable with an FDA-approved innovator drug. These biosimilars will not be chemically identical to the reference agent. Investigational studies conducted with biosimilar agents will li...
Despite the considerable success of molecular biology to understand diseases such as cancer, many fundamental questions remain unanswered. Most importantly, since the majority of gene products in the cell mediate their function together with other gene products, biological processes should be considered as complex networks of interconnected components. In other words, for any normal biological ...
The development of biologic agents for therapeutic purposes, or biomedicines, has seen an active area of research both at the bench and in clinical trials. There is mounting evidence that biologic products can provide effective therapy for diseases that have been unresponsive to traditional pharmacologic approaches. Monoclonal antibody therapy for cancer and rheumatologic diseases has become a ...
Keywords Biological product, investigational medicinal product (IMP), clinical trial, quality Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
Literature data about glycosides from sponges (Porifera, Demospongiae) are reviewed. Structural diversity, biological activities, taxonomic distribution and biological functions of these natural products are discussed.
A spectrophotometric method has been developed for the rapid measurement of the antimicrobial activity of natural products, including crude extracts or pure materials. The assay depends on the measurement of non-specific esterase activity using fluorescein diacetate (FDA) hydrolysis in broth cultures of microbes after they have been treated with test compounds. The assay is accurate, reproducib...
International trade in veterinary biological products has been restricted by the following factors: a) concerns that contaminated products could result in the introduction of foreign animal disease agents into the importing country b) differences between countries in the technical requirements for product registration. The provisions of the North American Free Trade Agreement (NAFTA) and the Ge...
As a chemical definition, natural products are small molecules derived from biological sources, most often being secondary metabolites (Anon 2007). The study of such natural products is therefore largely directed at the biological and chemical properties of isolated molecules. In this chapter the natural products definition is widened to include proteins and other larger molecules that can have...
Twenty-one years after Directive 2001/82/EC regulating veterinary medicinal products (VMPs) came into force, a new regulation will apply from 28 January 2022. Future applicants have to follow the requirements of Regulation (EU) 2019/6. This defines different products, non-biologicals (equivalent formerly defined pharmaceuticals), and biological products. Biological VMPs belong either class, non...
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