Drug, ethical

The one hundred ethical drugs most frequently prescribed in the USA in 1974 (J.C. Stokes, 1975) may be divided into three chemical classes ... 

Association(s) involved in selfregulation As above N/A PhAMA MOPI Nefarma N/A Uganda Pharm. Society Uganda Pharm. Dealers Association CAVEME, LAVE RBPP norms Pharm. Manufacturers Association Ethical Drugs Association... 

Cockburn, I. and R. Henderson (1994), Racing to invest Dynamics of competition in ethical drug discovery , Journal of Economics and Management Strategy, 3, pp. 481-519. 

Jackson, S. (1970). Evolution of the regulation of ethical drugs, American Economic Review 60 107-124. 

There is a further differentiation of ethical drugs into new drugs (those covered by patents) and generics (copies of drugs that have expired patents— see Case Study 10). Most of the descriptions in this book apply to new drugs. 

The various data, which must be submitted with applications for approval to manufacture ethical drugs, were specified in these notifications (Tables 23.1 and 23.2). 

Cockburn, lain, and Rebecca Henderson. 1994. Racing to Invest The Economics of Competition in Ethical Drug Discovery. Journal of Economics and Management Strategy 33 481-519. 

One element of the chemicals industry—pharmaceuticals—has already been the subject of intense study. Considerable attention has been given to the role that FDA regulation may or may not have played in an observed slowdown in the rate of development and commericalization of new ethical drugs. 

A basic premise of this paper is that prescription (or ethical) drugs have been providing and will continue to provide a benefit to society. The important thing about drug innovation should be that it is a benefit to societal health, not that it possibly means the financial growth of drug firms. 

Prescription Drug - also called an ethical drug. These medications must be prescribed by a licensed physician, dentist or veterinarian. They may be covered by a patent or be in the public domain. 

Drugs in Japan (Ethical Drugs) Yakugyo Jiho Tokyo. Japan, 1990 p981. 

Quick JD, Hogerzeil HV, Rago L, Reggi V, de Joncheere K. Ensuring ethical drug promotion—whose responsibility Lancet 2003 362 747. 

Such difficulties have apparently not affected the zeal of researchers. Nor have they diminished the sums devoted each year to research and development, which on the contrary have been constantly on the increase. This is because any major discovery may have worldwide portent. And in most developed countries there is a system of refunding to patients the cost of ethical drugs, so that a new active principle may provide the laboratory that has exclusive rights over it with a considerable source of profits even if such refunds are coupled with tight price controls. 

And while it is also true that thirty pharmaceutical companies alone account for 60 percent of worldwide ethical drug sales, the sums of money invested in research do not always get their full return. Thus it is that a small company like Janssen s laboratory, Janssen Pharmaceuticals, in Belgium, which was acquired in 1979 by Johnson and Johnson and which has among its discoveries diphenoxylate (1963) and loperamide (1975), has proved more innovative over the last fifteen years than the Rhone-Poulenc group, which has produced no major new molecule during the same time, although it devotes far more money to its research. 

Indeed, not much capital is needed to manufacture specialty chemicals compared with what is required for commodity chemicals. The development of new products is both quicker and less costly than it would be to find new processes for large-volume products or to bring to the market an original active principle for an ethical drug. 

An ethical drug that may also cause cyanide poisoning in overdose is the potent vascular smooth-muscle relaxant sodium nitroprusside. Although nitroprusside is related chemically to ferricyanide, unlike the latter it penetrates into erythrocytes and reacts with hemoglobin to release its cyanide (Smith and Kruszyna, 1974). Fortunately, the therapeutic margin for nitroprusside appears to be quite large. 

Product number 3 had a fading market position from 1962 through 1969 despite its price cuts, but then a 16% price cut in 1970 stopped the decline and added 14% to its market share. A further 27% cut in 1971 jumped its market share by another 40%. The market for ethical drugs responds remarkably vigorously to price changes, the myth of the price-insensitive prescribing physician to the contrary nothwithstanding. 

The PAL contains the specifications that are required to secure the quality, efficacy and safety of drugs (ethical and OTC drugs, quasi-drugs, cosmetics and medical devices). However, this chapter describes mainly ethical drugs. 

Ethical drugs are ones being supplied for use by physicians or dentists or under the prescription/direction of a physician or dentist (Notification No. 483 of the Pharmaceutical Affairs Bureau/PAB, 1980). 

The following drugs are classified as ethical drugs in principle ... 

Although required data for application of ethical drugs are shown in Tables 3 and 4, cases handled as exceptions cire shown in Table 5. 

When ethical drugs are to be manufactured by contract, the reason for the contracted manufacture, measured values, accelerated test, bioequivalence study, list of literature, etc., should be attached. It is necessary to attach a copy of the approval cancellation form for contracted manufacture and make a new application when changing from contracted mcmufacture to complete manufacture (See section Repackaging and Contracted Mcmufacturing). 

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