Principles and Practice of Pharmaceutical Medicine

sold at a considerably lower cost (70–90% below is typical) than the brand product. The above descrip- tion was painted with a b ...

patent infringement and provides the patentee 30 days in which to defend its patent by suing for patent infringement. The lawsui ...

the first approval of the new chemical entity. For new indications and new formulations of a pre- viously approved active agent, ...

for products to be sold in countries with stronger patent protection. 29.4 Biopharmaceuticals There is one type of medicine whic ...

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30 Complementary Medicines Anthony W. Fox Complementary medicines are very widely used. Their relevance to pharmaceutical medici ...

30.1 Terminology The Cochrane Collaboration defines ‘complemen- tary medicine’ as: ‘Complementary and alternative medicine (CAM) ...

therapeutic effect. Homeopathic medicines are available with and without prescriptions. Homeo- pathic prescribing resembles orth ...

also known as the ‘Fossil tree’ in the Far East, where most of its fossils are found. A specimen ofG. bilobawas the only living ...

and after doses as low as 1–5 mg, reported at an incidence rate of more than 100 cases per year to the US Food and Drug Administ ...

It is a curious assumption, and illogical that a complementary therapy could have sufficient pharmacological activity to improve ...

SECTION V Drug Regulation Introduction Sections I and II have covered fairly orthodox aspects of drug development. This Section ...

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31 United States Regulations 1 William Kennedy 31.1 The Food and Drug Administration: how we got to where we are Once upon a tim ...

was a void in national regulation of food and drugs. British patents, which had already been awarded to American drug recipes, a ...

Part of United States food and drug regulatory lore includes, at this point, an unlikely convergence of two famous characters. O ...

he became a Nobel laureate in 1938. The nostrum artists could hardly believe their luck: now they could peddle a drug that actua ...

required a big disaster to get things done. To be precise, thalidomide. Dr Frances Kelsey had the thalidomide applica- tion on h ...

30 months elapsed between NDA submission and approval, but the patent term restoration was only nine months; no new clinical tri ...

unsound, to expect 35 years of change to be cor- rected overnight, and at the same time, maintain a productive regulatory agency ...