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What Are Biologics, Biological Products and Biological Drugs?
2014Following 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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Infectious Disease Clinics of North America, 2020
The emergence of biologics has revolutionized the way physicians treat many autoimmune inflammatory conditions. Although biologics have become a vital component of the treatment approach to many inflammatory diseases, these agents may potentially disrupt the natural immune response against pathogens, thereby increasing the risk for infections.
Betty, Hsiao, Aisha, Khan, Insoo, Kang
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The emergence of biologics has revolutionized the way physicians treat many autoimmune inflammatory conditions. Although biologics have become a vital component of the treatment approach to many inflammatory diseases, these agents may potentially disrupt the natural immune response against pathogens, thereby increasing the risk for infections.
Betty, Hsiao, Aisha, Khan, Insoo, Kang
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Biological Naturalism and Biological Realism
2018This chapter summarizes the main principles of Biological Naturalism (BN) and Biological Realism (BR), and analyzes some of their similarities and differences. It contrasts the biological approach represented by BN and BR with another currently influential approach: information theories of consciousness, especially the Information Integration Theory ...
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Models of biological systems and biological processes
Pure and Applied Chemistry, 1994Abstract
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Postmarketing safety of biologics and biological devices
The Spine Journal, 2014Regardless of study design, the approval process of biologics and biological devices cannot identify every possible safety concern. Postmarketing safety surveillance can provide information based on real-world use of medical products in heterogeneous populations and is critical for identifying potentially serious adverse events, events that are too ...
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The Importance of Biological Databases in Biological Discovery
Current Protocols in Bioinformatics, 2003AbstractBiological databases play a central role in bioinformatics. They offer scientists the opportunity to access a wide variety of biologically relevant data, including the genomic sequences of an increasingly broad range of organisms. This unit provides a brief overview of major sequence databases and portals, such as GenBank, the UCSC Genome ...
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From Biological Data to Biological Knowledge
2007Large scale biological knowledge still organization remains a challenge in life sciences. Not only because related information is spread across several distributed information resources, but also because context dependent information retrieval suffers from an absence of semantic capabilities in biological databases.
Volker Stümpflen +2 more
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2012
Drug development is a complex process, requiring scientific and regulatory input at almost all stages from multiple groups of expertise. Small molecule development issues are covered in other parts of this volume. This chapter is devoted to discussing the large molecules, or biologics, and the particular nuances involved in developing these molecules ...
Kevin, Brady, Rob, Webster
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Drug development is a complex process, requiring scientific and regulatory input at almost all stages from multiple groups of expertise. Small molecule development issues are covered in other parts of this volume. This chapter is devoted to discussing the large molecules, or biologics, and the particular nuances involved in developing these molecules ...
Kevin, Brady, Rob, Webster
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Nature Reviews Genetics, 2004
Robustness is a ubiquitously observed property of biological systems. It is considered to be a fundamental feature of complex evolvable systems. It is attained by several underlying principles that are universal to both biological organisms and sophisticated engineering systems.
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Robustness is a ubiquitously observed property of biological systems. It is considered to be a fundamental feature of complex evolvable systems. It is attained by several underlying principles that are universal to both biological organisms and sophisticated engineering systems.
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