Exports of drugs

The exportation of drugs which have been withdrawn from the market because they have been considered a risk to public health is forbidden. 

The U.K. pharmaceutical industry is the fourth largest exporter of drugs in the world and the third leading export industry in the United Kingdom (22). How much of this success is due to the PPRS is a matter of conjecture, but the results are at least consistent with the second goal of the scheme. Whether British drug prices have been controlled by the system is also unclear. The Association of the British Pharmaceutical Industry reports that the U.K. retail price index increased by 29 percent between 1984 and 1989, while the pharmaceutical price index increased by only 22 percent. However, the Economist reported that drug prices outpaced the national inflation rate by more than 4 percent for the same time period (1 17). 

Members of the ABC family, which are involved in the cellular export of drugs, comprise multidrug resistance (MDR) 1/P-glycoprotein, the multidrug resistance associated proteins (MRP), and breast cancer resistance protein (BCRP). 

Only three countries, Tunisia, Uganda and Zimbabwe, do not issue a GMP certificate. The drug regulatory authorities in these three countries do conduct GMP inspections, but do not issue a specific document which indicates that a manufacturing plant has attained GMP standards. The MCAZ does, however, provide a GMP certificate at the manufacturer s request to facilitate international registration and export of products. In Malaysia, various types of certificates are issued GMP certificates Certificate of Pharmaceutical Product for export and Certificate of Free Sale for medical devices and cosmetic products. Cyprus has no clear criteria for issuing a GMP certificate instead. 

Chloride channels themselves may directly export drugs, particularly since certain chloride channels appear to act in the same manner as P-glycoprotein (multiple drug resistance protein) [227], which is involved in the export of vincristine [228,229], daunomycin [228,229], gramicidin D [230], and cyclosporin... 

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. 

The United States Drug Export Amendment Act of 1986. Permitted the export of... 

Reflecting the increasing importance of drug transporters in pharmacokinetics, we need to extend the historical two-phase concept for the metabolism of xenobiotics. As shown in Figure 15.1, the metabolic phases I (oxidation) and II (conjugation) are flanked by drug transporter phases 0 (uptake) and III (export). Phase 0 is the first step... 

Figure 15.2 Transport proteins involved in the intestinal absorption and the renal and hepatic excretion of drugs. In the intestine, drugs are taken up from the luminal side into enterocytes before the subsequent elimination into blood. In hepatocytes, drugs are taken up from the blood over the basolateral membrane and excreted over the canalicular membrane into bile. In the renal epithelium, drugs undergo secretion (drugs are taken up from the blood and excreted into the urine) or reabsorption (drugs are taken up from the urine and are excreted back into blood). Uptake transporters belonging to the SLC transporter superfamily are shown in red and export pumps...

One possibility to enhance, in a controlled manner, entry of drugs into the CNS would be to alter P-glycoprotein function at the blood-brain barrier. Such an enhancement could result from (1) direct modification of export pump function by inhibitors and intracellular signals or (2) bypassing the export pump by delivery systems not being recognized as substrates (e.g., nanoparticles or vector-coupled liposomes, which are taken up by endocytotic mechanisms) [58-65],... 

Multidrug resistance (MDR) is the name ascribed to the phenomenon whereby cancer cells and tumors develop resistance to chemotherapeutic agents. Conceptually, this can be viewed as a survival response whereby cancer cells endeavor to ward off cytotoxic compounds. Mechanistically, MDR is typically mediated by overexpression of P-glycoprotein (P-gp aka ABCB1) or other plasma membrane ATPases that export cytotoxic drugs used in chemotherapy, thereby reducing their efficacy. 

Under the FD C Act as enacted in 1938, adulterated and misbranded drugs may lawfully be exported but an unapproved new drug could not. This was a drafting error, but it was nonetheless enforced by FDA. Congress therefore enacted the Drug Export Amendments Act of 1986, which authorised the limited export of unapproved new human drugs and biological products after FDA had approved an export application. An export application could be approved only if... 

The Australian Drug Evaluation Committee makes medical and scientific evaluations of drugs referred to it by the minister or the secretary, and gives advice to the minister or secretary in relation to the import, export, manufacture and distribution of therapeutic goods. It is important to note that ADEC has an advisory function and... 

Historically, caffeine has played an important role in trade and politics and even now the export of coffee is an extremely important part of world trade for many countries. The health effects of caffeine have been the subject of numerous scientific inquiries, many scientific papers and conferences, and many books and articles. Perhaps the best book to combine both historical and health aspects of caffeine is The World of Caffeine - The Science and Culture of the World s Most Popular Drug by Bennett Alan Weinberg and Bonnie K. Bealer, published in 2001. This book gives a wonderful account of the interaction of caffeine and society from its ancient roots to present times, as well as a look at the health effects. A book devoted almost entirely to the health effects of caffeine is Caffeine and Health by Jack E. James, published in 1991. There is no lack of information on caffeine. 

The capillaries of the brain, the testes, and some other tissues are characterized by the absence of pores that permit aqueous diffusion. They may also contain high concentrations of drug export pumps (MDR pumps see text). These tissues are therefore protected or "sanctuary" sites from many circulating drugs. 

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