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Casting acute fractures. Part 2--Generic preparation and application of plaster slabs.

BACKGROUND: Slabs are ideal initial splints for the emergency treatment of many fractures. Construction of a broader slab of appropriate thickness with appropriate supportive elastic bandages produces a stronger, safer and more comfortable cast. OBJECTIVE: This article will introduce and demonstrate new materials and concepts that may be applied to slab construction in a generic fashion. It will form the basis for applying specific slabs demonstrated later in the series. DISCUSSION: The primary care physician is expected to apply slabs. Often his training has been minimal. The techniques shown are those used by full time casting technicians. These trade secrets are easily reproducible. Mastery will reduce material and labour costs for the general practitioner. The patient will have a stronger, more comfortable cast and fewer unplanned return visits.

Acute Disease↗

Relations between sales authorisation and pharmacopoeia.

At a time when the production and distribution of drugs and drug products is no longer confined within the national boundaries of particular countries, many thoughtful people are concerning themselves with the idea of standardisation of quality control procedures and specifications. For medicines currently marketed in different countries, a multitude of standards and specifications for both the raw materials and finished products exists. Plans for the regionalisation of drug standards have been put into operation but realistic estimates of progress agree that it will be measured and dignified. In one area there is the possibility for earlier action in reaching agreement on adequate specifications. The process of registration of a new drug substance for the first time presents an opportunity to make known to drug regulation authorities, academic and industrial pharmaceutical specialists, and other interested parties, the qualities and characteristics of the newly proposed agent and its dosage forms. A wide range of information will be needed on the chemical, physical, biological and physicochemical properties of the dosage forms as well as the raw materials of the active and inactive ingredients. Many of these requirements have already been described (3). There may be apprehension that the disclosure of some of this information could imperil the confidentiality of certain manufacturing processes or trade secrets, and adequate steps would be demanded to prevent this happening. The promulgation of a standard, at or shortly after the time of registration, should have been preceded by experimental tests, in the laboratories of the Authority, to verify the robustness of the analytical methodology. In some cases more extensive confirmation by collaborative study may be warranted. The elaboration of these concepts will be presented and examples brought forward of problems that have occurred in the past, and means to prevent them in the future.

Legislation, Pharmacy↗

When your contract manufacturer becomes your competitor.

PC maker Lenovo started out as a distributor of equipment made by IBM and other companies; now it has formed a joint venture with IBM and will eventually affix its own logo to its computers. Shanghai Automotive Industry Corporation (SAIC) started out manufacturing vehicles for Volkswagen and GM; now it's preparing to sell its own cars in China, Europe, and North America. Lenovo and SAIC represent a host of formerly anonymous makers of brand-name products that are breaking out of their defined roles and pushing the brands themselves aside. In this article, the authors explore the double-edged relationships original equipment manufacturers (OEMs) forge with their contract manufacturers (CMs). On the one hand, an OEM can reduce its labor costs, free up capital, and improve worker productivity by outsourcing all the manufacturing of a product. The company can then concentrate on value-adding activities--research and development, product design, and marketing, for instance. On the other hand, an OEM that retains a contract manufacturer may find itself immersed in a melodrama replete with promiscuity (the ambitious CM pursues liaisons with other OEMs), infidelity (the OEM's retailers and distributors shift their business to the upstart CM), and betrayal (the brazen CM transmits the OEM's intellectual property to the OEM's rivals or keeps it for itself when the contract is up). OEMs cannot simply terminate their outsourcing arrangements--they need contract manufacturers in order to keep specializing, adding value, and staying competitive. But OEMs can manage these relationships so that they don't become weak or the CMs too strong. Doing so requires modesty about revealing trade secrets; caution about whom one consorts with; and a judicious degree of intimacy, loyalty, and generosity toward partners and customers.

Commerce↗

The dermatologist and the right to know.

Recently the Federal Occupational Safety and Health Administration has promulgated a Hazard Communication Standard, as have many states and local governments. Regulations give physicians access to Material Safety Data Sheets and also to trade-secret information regarding chemical substances that their patients may come into contact with at work. This article describes how to access and interpret this information.

Allergens↗

Genetically-engineered microorganisms: I. Identification, classification, and strain history.

We have argued that accurate identification of the microorganism will form a cornerstone of the assessment of potential hazard. Appropriate methodology for identification exists, and is continually under development and refinement. Organizations such as the American Type Culture Collection will perform certified identifications for relatively low cost. Thus there appears to be little reason that an organism should not be identified insofar as current microbiology allows prior to submission for PMN review. We suggest that a complete microbiological characterization be considered an essential element of an acceptable PMN. To accomplish this, however, current institutional arrangements for the protection of trade secret information needed in the process of identification may need to be improved. An accurate identification of the strain will often provide access to important information with which to evaluate its ecology, pathogenicity, biochemistry, and genetics. Specialized texts, the scientific literature, and professional consultation are ready sources of such information. However, a major effort should be made to establish a data base that can specifically address the needs of biohazard evaluation. This could be done, in part, by collecting information about the construction, and about the behavior in the environment of genetically-engineered microorganisms that are now under development and will soon be tested or used. Identification information may also eventually be useful for the formulation of hypotheses about possible modes of harm or about relative safety, based on phylogenetic relationships. This is a very difficult undertaking at present, however. Microbial taxonomy is currently in a process of radical reevaluation as new macromolecular sequence information reveals previously unsuspected phylogenetic relationships, and disturbs categorizations based on older types of traits such as morphology, etc. This means that both inferences about relative safety and about possible modes of harm from taxonomic relationships must be highly tentative based on current information. Regulatory authorities may wish to consider requesting confirmatory DNA hybridization data or other macromolecular sequence comparisons in cases where strong arguments related to safety must be made from taxonomic information in relatively poorly studied groups of organisms. Detailed strain histories would provide valuable information for safety evaluations.(ABSTRACT TRUNCATED AT 400 WORDS)

Bacteria↗

A patent law primer for clinical chemists and other scientists.

Patenting and commercialization by academic scientists, despite potential drawbacks, are on balance highly desirable if technology is to be transferred from the laboratory to the public use, and if the scientist and his institution are to be encouraged to participate in this transfer. If that premise is accepted, there is much that academic institutions can do to foster utilization of their biotechnological discoveries. Such institutions should have a patent policy that is known to all and that includes a professional patent administrator and clear administrative procedures for carrying out such policy. Scientists should be trained to recognize and protect their inventions and to appropriately disclose their inventions to their patent officers. Ideally, scientists should know the rudiments of the patent statutes of their own country and should be aware of what constitutes trade secrets. Scientists should be given guidance in working with patent attorneys in the preparation and prosecution of patent applications. Finally, given human nature, institutions should see to it that their scientists are provided with a suitable environment in which to invent, and appropriate incentives to do so.

Chemistry, Clinical↗

Chaperones of the type III secretion pathway: jacks of all trades.

The type III secretion (TTS) pathway is used by many Gram-negative bacteria to inject virulence proteins into cells of their host. The activity of the TTS apparatus is controlled by external signals and, in certain conditions, production and secretion are not coupled. Storage of some proteins before secretion involves their association with specific chaperones. Three classes of TTS chaperones have been distinguished according to whether they associate with: (i) one; (ii) several effector proteins; or (iii) the two translocators that allow passage of effectors across the membrane of eukaryotic cells. These chaperones are required for stabilization of their substrate(s) and prevention of their premature interactions with other partners during storage. They also play a role in secretion of their substrate(s). Some chaperones are also involved in transcriptional regulation of certain genes in response to the activity of secretion. The flagellar export apparatus is closely related to the TTS apparatus and some proteins of the flagellar export system have also been proposed to be chaperones that prevent premature interactions between the flagellum subunits.

Bacterial Proteins↗