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Specialty drugs, a recent classification of pharmaceuticals, are high-cost drugs that are often biologics. [ 7 ] [ 8 ] [ 9 ] The European Medicines Agency uses the term advanced therapy medicinal products (ATMPs) for medicines for human use that are "based on genes, cells, or tissue engineering", [ 10 ] including gene therapy medicines, somatic ...
A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. [1]
In pharmacology, biological activity or pharmacological activity describes the beneficial or adverse effects of a drug on living matter. [1] [2] When a drug is a complex chemical mixture, this activity is exerted by the substance's active ingredient or pharmacophore but can be modified by the other constituents. Among the various properties of ...
Time course of drug plasma concentrations over 96 hours following oral administrations every 24 hours (τ). Absorption half-life 1 h, elimination half-life 12 h. Biological half-life ( elimination half-life , pharmacological half-life ) is the time taken for concentration of a biological substance (such as a medication ) to decrease from its ...
The Biologics Control Act of 1902 required that federal government grant premarket approval for every biological drug and for the process and facility producing such drugs. This was followed in 1906 by the Pure Food and Drugs Act, which forbade the interstate distribution of adulterated or misbranded foods and drugs. A drug was considered ...
The nomenclature of monoclonal antibodies is a naming scheme for assigning generic, or nonproprietary, names to monoclonal antibodies.An antibody is a protein that is produced in B cells and used by the immune system of humans and other vertebrate animals to identify a specific foreign object like a bacterium or a virus.
Drug nomenclature is the systematic naming of drugs, especially pharmaceutical drugs.In the majority of circumstances, drugs have 3 types of names: chemical names, the most important of which is the IUPAC name; generic or nonproprietary names, the most important of which are international nonproprietary names (INNs); and trade names, which are brand names. [1]
Other drugs which may provide relief include acitretin, ciclosporin, and methotrexate, but since these drugs have their own major side effects, doctors and patients should discuss whether to try one of these or a biologic first. [4] Most biologics are injections so are not appropriate for use by someone with intense fear of needles. [4]