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Regulation of drugs

Pregnane X Receptor, Nuclear Receptor Regulation of Drug-metabolizing P450-Enzymes. [Pg.1054]

The core legislation governing the regulation of drugs in the EU is contained in two base Directives, which provide the framework for regulation of medicines at national level. These are ... [Pg.7]

European Aspects of the Regulation of Drug Products with Particular Reference to Development Pharmaceutics... [Pg.644]

The regulation of drug prices is an instrument that is used in all the countries of the European Union (EU), although in different modes. Table 3.1 shows the... [Pg.39]

Defect Action Levels (DALs) of, 23 160 organization and roles of, 21 571-573 regulation of biological products, 21 576 regulation of cosmetics, 21 579-580 regulation of drug products, 21 573-576 regulation of food products, 21 578-579... [Pg.986]

Leber, P. (1987). FDA The federal regulations of drug development. In Psychopharmacology The Third Generation of Progress (Meltzer, H.Y., ed.). Raven Press, New York, pp. 1675-1683. [Pg.28]

Controlled Substance Act and Controlled Substances Import and Export Act. Removed regulation of drug abuse from FDA (transferred to the Drag Enforcement Agency) and provided for stringent regulation of pharmaceuticals with abuse potential. [Pg.32]

Anon. (1998a). Annual Report of the Pharmaceutical Research and Manufacturer s Association. (Priority 2 Improved FDA Regulation of Drug Development). [Pg.95]

Merrill, R. (1994). Regulation of drugs and devices An evolution. Health Affairs 13 47-69. [Pg.98]

The regulation of drug-metabolizing enzymes by PXR is involved in clinical drug-drug interactions, in which one drug accelerates the metabolism of a second medicine and may change or cause adverse results. Because CYP enzymes can... [Pg.300]

Staudinger, J.L., Madan, A., Carol, K.M. and Parkinson, A. (2003) Regulation of drug transporter gene expression by nuclear receptors. Drug Metabolism and Disposition, 31, 523-527. [Pg.313]

In summary, the role of dissolution testing as a surrogate for BE studies in humans has assumed increasing importance in the regulation of drug products. It is more than likely that in the coming years, the application of biowaivers based... [Pg.346]

Exhibit 7.2 presents a brief history of the FDA. For the purpose of regulation of drugs, the relevant centers are the CDER and CBER. [Pg.210]

Frye RF, Matzke GR, Adedoyin A, et al. Validation of the five-drug Pittsburg Cocktail approach for assessment of selective regulation of drug-... [Pg.196]

The thalidomide disaster in 1961 was to blow apart the complacency on regulation of drugs. The confidence in the therapeutic revolution promised by the pharmaceutical industry was... [Pg.460]

The regulation of drug products by the United States Food and Drug Administration... [Pg.565]


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Drugs regulation

FXR-Dependent Regulation of Basolateral Drug and Bile Acid Uptake

Federal regulation of drugs

Historical development of drug regulation

International Regulation of Chiral Drugs

Misuse of Drugs Regulations

Molecular Mechanism of PXR- and CAR-Dependent Drug Transporter Regulation

Monitoring and evaluating the effectiveness of drug regulation

Nuclear Receptor-Mediated Regulation of Drug Transporters

Regulation of drug products

Regulation of drugs Class

Regulation of drugs Schedule

Regulation of veterinary drugs

US Regulation of OTC Drugs

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