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With stability testing, pharmaceutical industry inspects the quality of drug substances and drug products as per the guidelines outlined by US Food and Drug Administration and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to make sure that they retained the quality over the period of time.
In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles. [1]
Design space verification is a part of process validation as defined by the EMA in conjunction with the FDA. Its purpose is to guarantee end product quality within a range of manufacturing boundaries. The effects of scale up activities should be fully understood by the manufacturer.
Clinically, the particle size of a drug can affect its release from dosage forms that are administered orally, parenterally, rectally and topically. The successful formulation of suspensions , emulsions and tablets ; both physical stability and pharmacological response also depends on the particle size achieved in the product.
To reduce the cost to the military of maintaining stockpiles of certain pharmaceuticals, the United States Department of Defense and the Food and Drug Administration operate a joint initiative known as the Shelf-Life Extension Program (SLEP), which evaluates the long-term effectiveness of medications stockpiled by the DoD and other government agencies.
In clinical practice, this means that it takes 4 to 5 times the half-life for a drug's serum concentration to reach steady state after regular dosing is started, stopped, or the dose changed. So, for example, digoxin has a half-life (or t 1 / 2 ) of 24–36 h; this means that a change in the dose will take the best part of a week to ...
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
Tablets may become unstable and the drug may degrade. High barrier packaging (including seals) is necessary but, by itself, is often not enough. Shelf life of a moisture-sensitive drug can be extended by means of desiccants. [11] Several types of dessicants are available; the type and quantity need to be matched to the particular drug and package.