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Traditional biomarkers, including C-reactive protein, leukocytes, erythrocyte sedimentation rate, and clinical signs and symptoms, are not sufficiently sensitive or specific enough to guide treatment decisions in infectious febrile diseases. Procalcitonin ...

A) Regulating biologic medications raises new issues for both state and federal policymakers because of their complexity, especially when or how they can be interchanged. In 2015 the first rival biosimilar was approved by the FDA, by early 2018 there were eight such biosimilars, but they await an additional step to be determined interchangeable. 41 states have now enacted laws defining the state laws. B) 40 states have enacted separate "Right to Try," not-yet-approved drugs by passing state le

For patients with chronic illnesses, such as rheumatoid arthritis, multiple sclerosis and cancer, the introduction and development of biologic therapies has been a significant boon to their health and quality of life. Still, the process of finding the correct regimen can be painstaking, and involve months, or even years, of trial and error before a physician and their patient find a therapy that

Acute-phase reactants such as erythrocyte sedimentation rate and C-reactive protein have traditionally been used as markers for inflammation and as a measure of “sickness index” in infectious and noninfectious conditions. In the last decade, ...

Interchangeability Interchangeability is defined by statute in the United States to mean that the product may be substituted for the reference product without the intervention of the physician who prescribed the reference product. The legal standard for interchangeability is an additional standard beyond demonstration of biosimilarity. According to guidance issued by the FDA in May 2019, in order for a biological product to be deemed interchangeable, the information submitted must be sufficient to show that: The biological product is biosimilar to the reference product and can be expected to produce the same result as the reference product in any given patient For a biologic product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch Substitutions In the United States, although Federal law gives the FDA authority to license biologic products as interchangeable, it is the state laws that govern the substitution of biologics and pharmaceuticals.

An alternative approach for the scale-up of ribbon formation during roller compaction was investigated, which required only one batch at the commercial scale to set the operational conditions. The scale-up of ribbon formation was based on a probability method. It was sufficient in describing the mec …

Big changes are afoot in how Medicare reimburses for Part B drugs, and the reaction to the potential changes has stakeholders scurrying in every direction.

Senator Cardin (D-MD) proposed to dramatically scale back individual and corporate income taxes and finance that cut with his Progressive Consumption Tax.

Abstract. Governments and financial institutions in several jurisdictions are planning or implementing nonmedical/‘forced’ switches by cutting drug coverage for

Cellular & Molecular Immunology - Sepsis-associated severe interleukin-6 storm in critical...

The aims of this pilot study were to: i) conduct a thorough behavioral and medical evaluation of cats presenting for chronic fabric ingestion; and ii) implement specific treatments for conditions identified and evaluate the outcome of treatment on fabric ingestion. Eight cats which ingested fabric a …

A framework of Human Error Probability (HEP) parameters, which is needed for Human Reliability Analysis (HRA) within a practice of Probabilistic Safety Assessment (PSA) of Nuclear Power Plant is first proposed. Then a laboratory experiment was conducted in order to construct a computer simulation mo …

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Intellectual property in India is a subordinate office of the Govt of India & administers the Indian law for Patents, Designs, Trade Marks & Geographical Indica