Drug manufacture

OTC Facts and Figures, Nonprescription Drug Manufacturers Association, Washington, D.C., 1995. 

Canadian Chemical Producers Association (CCPA), 258 Canadian Drug Manufacturers Association (CDMA), 259 Canadian Environment Industry Association, Ontario (CEIA Ontario), 275... 

The Veterinary Drug Manufacturing Encyclopedia. The present volume deals only in "people drugs" as did its pradecessor volume but some drugs find application In both areas. 

Sittig, M., Veterinary Drug Manufacturing Encyclopedia, Park Ridge, NJ, Noyes Publi-... 

Shindo and Caldwell reported that specific reference was made to chiral drugs in only two places in the Japanese Requirements for Drug Manufacturing Approval. 

Aldehydes and ketones are converted into alkenes by means of a nucleophilic addition called the Wittig reaction. The reaction has no direct biological counterpart but is important both because of its wide use in the laboratory and drug manufacture and because of its mechanistic similarity to reactions of the coenzyme thiamin diphosphate, which well see in Section 29.6. 

Where steam is used for sterilization, hospital duty, food and drug manufacturing processes, or steam humidification purposes, there generally is a reluctance (or mandated prohibition) to employ amines as a treatment for steam-condensate line corrosion protection. Clean-steam... 

Recycled condensate often is of higher quality than FW, although in facilities with extremely long runs of steam and condensate lines, or where amine treatments are not used (e.g., some food processors, hospitals, drug manufacturers, etc.) and in high heat-flux power boiler plants, there is a tendency for the condensate to be contaminated by iron and smaller levels of copper. 

Kefauver-Harris Drug Amendments are passed. These require drug manufacturers to prove... 

Figure 11.7 Schematic layout of a drug-manufacturing facility.

PDA Compliance Programme Guidance Manual Programme 7536.002, Drug Manufacturing Inspections... 

There is always the possibility that there may come a time when a laboratory discovers itself doing work in connection with illegal activities, such as drug manufacturing. Here is where the whistle must be blowm. If the case is not reported to authorities, the laboratory could become a co-defendant in a prosecution. 

The upshot of this trend toward visibility of research should reduce liability on the part of drug manufacturers and researchers, increase the likelihood that accuracy is enhanced, and produce more informed drug users. The question of accuracy undergirds the topic of liability, and if trends toward pharmacogenetics and individualized drug therapy hold, the importance of accuracy and subsequent liability will only increase. 

The task of the DRA is to serve the public. Its operations must therefore be transparent to both clients (e.g. drug manufacturers) and consumers. Communication with clients should be a routine activity throughout the regulatory process. Information regarding its functions and the results of decisions should also be communicated regularly to the public. 

LC Lappas. The manufacture of hard gelatin capsules, paper presented to Research and Development Section, The American Drug Manufacturers Association, Atlantic City, NJ, October 8, 1954. 

Durometer hardness is defined as the measure of resistance to indentation using either a macro- or microhardness tester. To the pharmaceutical drug manufacturer, hardness is important because of its relationship to ultimate mechanical properties— particularly modulus. In general, softer compounds of the same elastomer base have better coring and reseal properties, whereas harder compounds tend to process better on high-speed filling lines. 

Nonprescription Drug Manufacturers Association established voluntary limits for alcohol content of nonprescription products [72] ... 

One distinction between drugs and dietary supplements is how they are regulated by the FDA. Unlike for drugs, manufacturers do not have to provide FDA with evidence that dietary... 

Unlike with drugs, manufacturers of dietary supplements do not have to disclose potential side effects of their products to consumers. The label of the supplement may contain a cautionary statement, but the lack of such a statement does not mean that no adverse effects are associated with the product. Dietary supplements may also interfere with the activity of other medicines (drugs or other supplements) an individual is taking. Also unlike with drugs, the manufacturer is not required to disclose these interactions to the consumer. 

A large drug manufacturer has decided to study this molecule and formulate it into a drug if it proves to be safe and effective. As an aside, the San Bushmen of the Kalahari desert are currently impoverished and oppressed. If P57 becomes a money-making drug in developed countries, it may mean a better life for people of this tribe, since they will receive royalties (money) when the drug is sold. This drug is very early in the research process and it will be several years before it could be available in the United States. 

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