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This article was published in the following journal.
Name: The New England journal of medicine
The cost of prescription drugs in the U.S. continues to be a source of concern for patients, caregivers, and policymakers. Drug prices typically decline rapidly once generic drugs receive U.S. Food an...
Quantitative methods and modeling (QMM) covers a broad spectrum of toolsets of which physiologically-based models and quantitative clinical pharmacology are most critical for generic drugs. QMM has be...
Many markets maintain a nontrivial mix of both nonprofit and for-profit firms, particularly in health care industries such as hospice, nursing homes, and home health. What are the effects of coexisten...
The purpose of the US Food and Drug Administration's Marketed Unapproved Drugs Initiative is to decrease marketing of older unapproved medications. The administration has recently extended its rulings...
The experience gained with biosimilars has made it clear that copies of complex drugs are more challenging to produce and put on the market than generics. In the case of so-called nonbiological comple...
Proton pump inhibitors (PPI) are used to decrease stomach acid secretion. A generic form of omeprazole, one of the PPIs, is on the market. With cheaper than brand name PPIs, it is unclea...
Some epilepsy patients are described as GB when they have worsened seizures or side effects related to switching between brand name and generic, or between generic antiepileptic drug (AED)...
The purpose of this study is to determine the mid levels of the tenofovir, lamivudine, and efavirenz, and 48 weeks safety and efficacy of the generic fixed dose combination of tenofovir /...
The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.015% to Picato gel, 0.015% by establishing the therapeutic comparabili...
The previous two studies of generic GPO saquinavir failed to prove bioequivalence. In this study the bio-equivalence will be investigated in healthy Thai volunteers, to see whether the gen...
Removal of a drug from the market due to the identification of an intrinsic property of the drug that results in a serious risk to public health.
The evaluation of incidents involving the loss of function of a device. These evaluations are used for a variety of purposes such as to determine the failure rates, the causes of failures, costs of failures, and the reliability and maintainability of devices.
Removal of a drug from the market due to a problem occurring in the manufacture or distribution of the product.
Drugs whose drug name is not protected by a trademark. They may be manufactured by several companies.
A drug that has analgesic and anti-inflammatory properties. Following reports of adverse reactions including reports of carcinogenicity in animal studies it was withdrawn from the market worldwide. (From Martindale, The Extra Pharmacopoeia, 30th ed, p21)
A generic drug (generic drugs, short: generics) is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended u...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...