Percutaneous Administration

The absorption of drugs through the skin should be a difficult matter since the function of the skin is to act as a barrier between the outside environment and the vulnerable tissues under the skin. Yet drugs are absorbed, sometimes quite efficiently, from the skin. A major function of skin is to retard the diffusion and evaporation of water from within the body, except at the sweat glands. The stratum corneum, also known as the horny layer, which is densely packed with keratin, is responsible...

Intravenous Administration

The direct administration of drugs into veins is the only route where bioavailability considerations are not relevant. This route provides an almost instantaneous response with controllability of the rate of drug input into the body. This route is especially suitable for those drugs which cannot be absorbed adequately from the gastrointestinal tract or tissues depots (e.g., intramuscular administration) or where there is a significant first pass effect upon oral administration. The drugs which...

Biowaiver Courier Ma Gujarati Natak

A flexible technology for modified release of drugs multi layered tablets. J Control Release 2004 97(3) 393-405. Abrams J. Glyceryl trinitrate (nitroglycerin) and the organic nitrates. Choosing the method of administration. Drugs 1987 34(3) 391-403. Aldridge MA, Ito MK. Colesevelam hydrochloride a novel bile acid-binding resin. Ann Pharmacother 2001 35(7-8) 898-907. Atkins PJ. Dry powder inhalers an overview. Respir Care 2005 50(10) 1304-12 (discussion 1312). Bach M, Lippold...

Background

Applicants submitting a new drug application NDA or new animal drug application NADA under the provisions of section 505 b in the Federal Food, Drug, and Cosmetic Act FDC Act are required to document bioavailability BA 21 CFR 320.21 a . If approved, an NDA drug product may subsequently become a reference listed drug RLD . Under section 505 j of the Act, a sponsor of an abbreviated new drug application ANDA or abbreviated new animal drug application ANADA must document first pharmaceutical...