Pharmaceutical manufacturers

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  • This Handbook of Manufacturing Techniques focuses on a new aspect of the drug development challenge: producing and administering the physical drug products that we hope are going to provide valuable new pharmacotherapeutic tools in medicine. These 34 chapters cover the full range of approaches to developing and producing new formulations and new approaches to drug delivery. Also addressed are approaches to the issues of producing and packaging these drug products (that is, formulations).

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  • Analytical technology transfer and manufacturing is the mechanism by which knowledge acquired about a process for making a pharmaceutical active ingredient or dosage form during the clinical development phase is transferred from research and development to commercial scale-up operation or shared between internal groups or with third parties. Analytical technology transfer guarantees that laboratories can routinely execute tests, obtain acceptable results, and be able to accurately and independently judge the quality of commercial batches.

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  • Automation of coating processes Graham C.Cole SUMMARY Current Good Manufacturing Practice (cGMP) and the demands of the regulatory authorities worldwide requires greater care in the design of manufacturing facilities, the selection of materials used in their construction, their layout, the equipment used in the preparation of tablets to be coated and the coating operation. It is claimed that robotic systems will eventually take over all processing tasks! (Kanig & Rudic, 1986).

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  • The art of compliance is a craft much like that of a carpenter who learns to work with various kinds of wood and designs. Ours is an industry wrought with differences. While the regulations that govern FDA-regulated industries are proscribed, how the regulations are interpreted and applied really depends on experience and how well one has mastered the craft of compliance. There are no proscribed procedures, but there are guideposts common to all FDA-regulated industries, whether a firm manufactures medical devices, pharmaceuticals, or biological products....

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  • hemical and industrial manufacturing processes often require temperature, humid- ity, and other environmental parameters to remain in a small, fixed range that varies over time [11]. Should the temperature fall outside this range, manufacturers risk costly failures that must be avoided. Thus, they currently employ a range of wired sensing to avoid such problems [25,13]. Interestingly, companies in this area (e.g.

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  • This is a comprehensive source of information on the application of ion chromatography (IC) in the analysis of pharmaceutical drugs and biologicals. This book, with contributors from academia, pharma, the biotech industry, and instrument manufacturing, presents the different perspectives, experience, and expertise of the thought leaders of IC in a comprehensive manner. It explores potential IC applications in different aspects of product development and quality control testing.

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  • There is increasing political and environmental pressure on industry to clean up the water which it uses in many processes, and to re-use this water where possible. This cleaning is done using specially-developed industrial membranes and this book covers the types and design of membranes, how they work and in which industries they are used. Special attention is paid to the textile, food/ beverage, pharmaceutical, oil and pulp and paper industries where such membranes are in regular use.

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  • It is interesting to look at the major sources of waste from within the chemical industry. Bulk chemical production is normally thought of as a ‘dirty’ industry and historically this has been the case. As the industry became more competitive, more economic processes needed to be developed and it became unacceptable (and non- viable) to produce the same amount of waste as 30 years ago. Today it is the speciality and pharmaceutical industries which produce most waste (at least...

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  • Fossil fuel combustion for transportation contributes to air pollution, and air pollution degrades human health. However, the path from transportation to human health costs is anything but straightforward. Which pollutants are produced in which proportions depend on a number of factors, including the vehicle and fuel used and the driving conditions of a particular trip. These emissions are dispersed into the ambient air according to atmospheric conditions, which also influence the extent to which they react to form secondary pollutants.

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  • First among the threats to forest biodiversity identified by BirdLife International and the Forest Inventory and Planning Institute (FIPI) is hunting, because of the value and rarity of the game, followed by firewood and other non- timber forest product (NTFP) collection, timber cutting, forest fires (including human-made as part of scrap metal collection) and clearance of forest land for agriculture (Le Trong Trai et al. 2001). But the threats are usually specific to each site, and detailed information is needed for each location, as we did in Khe Tran.

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  • Under free ranging conditions, the frequency of drinking water by camel depends on a number of factors such as the ambient temperature, the water content of the feed and the physiological status of the animal. Lactating females obviously require more water than dry cows, bulls or castrates. It is said that throughout the winter period, camels may not have access to free water. There is an historial record held by camels in Sudan where it was noted 86 years ago that a large herd of camels at a well on May 11, 1917 were drinking free water for the...

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  • The pharmaceutical industry manufactures biological products, medicinal chemicals, botanical products, and the pharmaceutical products covered by Standard Industrial Classification Code Numbers 2831, 2833, and 2834, as well as other commodities. The industry is characterized by a diversity of products, processes, plant sizes, as well as wastewater quantity and quality. In fact, the pharmaceutical industry represents a range of industries with operations and processes as diverse as its products.

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  • In addition to the traditional FFS Medicare or Medicare Managed Care (MMC) insurance, many elderly buy supplemental insurance policies to cover prescription drugs or catastrophic expenses. These supplemental policies are known as MediGap plans, because they help fill gaps in the available health insurance coverage. Some Medicare beneficiaries are dual eligibles – covered by both Medicare (health insurance for the aged) and Medicaid (health insurance for the poor with chronic disabilities or endstage renal disease).

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  • Qualification requirements are a prime consideration in determining positions covered by the GS-1146-0 Series. Positions are classifiable to this series when there is a requirement for incumbents to have a practical knowledge of the various marketing elements, functions and/or practices, or a knowledge of the requirements of one or more laws, acts or other statutory provisions relating to the particular program and/or commodity involved. Positions concerned with marketing activities, but which require incumbents to possess other professional or specialized knowledge (e.g.

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  • Hollywood’s loss, in terms of the general narrowing of the horizons of possibility at the heart of the studio-led machine, was to be the gain of a newly consolidating form of independent production and distribution that was beginning to take shape during the 1980s, and into which some of the inheritance of the Renaissance was carried. The term ‘independent’ has had rather different connotations at different periods in the history of American cinema. In the 1930s, for example, it signified ‘something less than trash’.

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  • Addiction and recovery have been topics of Hollywood films and movies of the week and are increasingly integrated into mainstream television shows through the inclusion of addicted characters. Now the producers of reality shows have entered the field with the new American television show Intervention, on the A&E channel.

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  • As seen in Table 7, both Planned Parenthood and other WHP clinics typically offer a comprehensive range of contraceptive methods. The methods include oral contraceptives (the Pill) as well as long-acting reversible contraceptives (LARCs) such as intrauterine devices (IUDs), implants (e.g., Implanon), or injectables (e.g., Depo-Provera). LARCs are particularly important because they are the most effective in preventing unintended pregnancies and have lower failure rates.

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  • When starting hormonal contraception after POEC (Levonelle 1500® or Levonelle One Step®) additional contraception should be advised until contraceptive efficacy is established (see Summary on page iv). There are no data on quick starting hormonal contraception after use of the emergency contraceptive, ulipristal acetate (UPA) (ellaOne®). As UPA is a progesterone receptor modulator that blocks the action of progesterone, it may affect the contraceptive efficacy of hormonal methods.35,36 However, no interaction studies have been carried out to date.

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  • A strength is an asset or a resource that can be used to improve a community’s competitive position, such as a natural attraction, historic buildings, or a strong retail base. A weakness is just the opposite, a resource or capability that may cause your community to have a less competitive position, which can adversely affect tourism. For instance, empty commercial space or unattractive vacant buildings are categorized as weaknesses.

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  • On September 1st , Switzerland announced it was extending a deadline for meeting its targets for reducing noise from road traffic. A new amendment to a federal ordinance on noise pollution will give national and local authorities until 2015 to install noise-reduction barriers along highways and until 2018 to install similar barriers along other major roads. The barriers were originally due to be in place by March 2002, under the 1986 federal ordinance. However, only around 30 percent of the roads targeted for remedial measures had barriers installed by that date.

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