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Dalbavancin is the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, dalbavancin was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat serious or life ...
A Qualified Intellectual Disability Professional, often referred to as a QIDP for short is a professional staff working with people in community homes who have intellectual and developmental disabilities and was previously known as a Qualified Mental Retardation Professional or QMRP. [1]
Description - includes the proprietary name (if any), nonproprietary name, dosage form(s), qualitative and/or quantitative ingredient information, the pharmacologic or therapeutic class of the drug, chemical name and structural formula of the drug, and if appropriate, other important chemical or physical information, such as physical constants ...
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Over the past few years, the Food and Drug Administration has approved various new treatments for Alzhimer's disease, but are they making a real difference? This Special Feature investigates.
Methylphenidate, sold under the brand names Ritalin (/ ˈ r ɪ t ə l ɪ n / RIT-ə-lin) and Concerta (/ k ə n ˈ s ɜːr t ə / kən-SUR-tə) [citation needed] among others, is a central nervous system (CNS) stimulant used medically to treat attention deficit hyperactivity disorder (ADHD) and, to a lesser extent, narcolepsy.
Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patients. For orally administered drugs, this usually involves incorporating the drug into a tablet or a capsule. It is important to make the distinction that a tablet contains a variety of other potentially inert substances apart from ...
Even slight differences in manufacturing might result in therapeutic or safety differences not to be attributed to a known or defined component. The existing and defined biosimilar pathway , taking into consideration the complexity of biologics and its follow-on products, is neither applicable for NBCDs and its similars.