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with inactive ingredients. The term also includes a nished dosage form that does not contain an active ingredient but is intended to be used as a placebo. Placebo is used especially during safety and ef cacy studies during drug development and in preclinical animal studies or human clinical trials. Active ingredient (also known as active drug substance) means any component that is intended to furnish pharmacological activity or other direct effect on the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of humans or other animals [21 CFR Part 210.3(b)(7)]. Inactive ingredient (also known as excipient) means any component other than an active ingredient [21 CFR Part 210.3(b)(8)]. One of the important aspects of GMP regulations is the quality control during manufacturing to ensure that the drug products are free of contamination from objectionable microorganisms. GMPs [1] require that the personnel engaged in drug product manufacture wear protective apparel such as head, face, hand, and arm covering (garbing) as necessary to protect drug products from contamination [Part 211, Section 211.28(a)]. The regulations also require that the ow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings be designed to prevent contamination [211.42(b)]. Contamination prevention also includes designation of separate or de ned areas or such other control systems for the manufacturing operations as are necessary to prevent contamination [211.42(c)]. Appropriate equipment is required for adequate control over microorganisms [211.46(b)]. Adequate exhaust systems or other systems adequate to control contaminants are required where air contamination is likely to occur during production [211.46(c)]. Water is used in many areas of pharmaceutical manufacturing operations. GMPs require [211.48(a)] that incoming potable water into the manufacturing plant should comply with the U.S. Environmental Protection Agency s (EPA s) Primary Drinking Water Regulations (40 CFR Part 141), where control of microbiological contamination in potable water is de ned. GMPs require written procedures be designed to prevent contamination of equipment, components, drug product containers, closures, packaging, and labeling materials or drug products and that such procedures be followed [21 CFR Part 211.56(c)]. Equipment cleaning and maintenance are also required to prevent contamination [21 CFR Part 211.67(a)]. Components and drug product containers and closures should at all times be handled and stored in a manner to prevent contamination [21 CFR Part 211.80(b)]. GMPs also require testing and release as described in 21 CFR Part 211.84(d)(6), which states that each lot of component, drug product container, or closure that is liable to microbiological contamination that is objectionable in view of its intended use should be subjected to microbiological tests before use. Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile, should be established and followed [21 CFR Part 211.113(a)]. GMP regulations in 21 CFR Part 211.165(b) require appropriate laboratory testing be performed, as necessary, of each batch of drug product required to be free of objectionable microorganisms. GMPs for Active Pharmaceutical Ingredients
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where the unknowns are the time-domain voltage samples at the 2N + 1 sampling instants: vk = v(tk ) k = 0, 1, . . . , 2N (1.98)
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If g,(8) may be reparameterized by a number of parameters smaller than the dimension K of 8, then the columns of ag(6')/aOT are linearly dependent and can be nontrivially linearly combined into an N x 1 null vector:
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9.5. BIODEGRADABLE POLYMERS FROM PETROLEUM-DERIVED PRODUCTS Polycaprolactone Poly- -caprolactone (PCL) is a semicrystalline, thermoplastic, linear aliphatic polyester synthesized by the ring-opening polymerization of -caprolactone and is produced commercially by Union Carbide Dow (Midland, MI) and Rhone-Poulenc (Collegeville, PA). This polymer has a melting point of approximately 62 C and a glass transition temperature of approximately 60 C. PCL is readily degraded and mineralized by a variety of microorganisms [45]:
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Add row button Figure 13-8: To add a new row above a specific existing row, use the Add Row button in the Cell tab of the Table Inspector.
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Figure 12.9 Possible mechanisms to explain the association of hypertension with obesity.
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between discovery and publication of knowledge. The development of computers made possible rapid recovery, comparison and analysis of very large amounts of information in almost real time. Bioinformatics is the application of computer science to the solution of biological problems. Up to the mid-1990s this was the preserve of specialists trained in elds such as computer science, structural chemistry and advanced mathematics. However, the explosion in computer power (larger memories, faster processors, better and faster programs) in the late 1990s have made bioinformatics increasingly part of the toolkit essential for modern molecular life scientists. Spin-offs of this include large-scale sequencing projects such as the human genome project (HGP), the unprecedented and continuing increase in structures held in the PDB and an activity known as database mining where scientists use databases rather than conventional screening
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Figure 15-29: Symmetrical tolerances.
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What-If Analysis
The parser then processes the contents of the string variable, calling your event handler functions as appropriate, until it s finished reading all the XML data. If the parser managed to parse all the data successfully it returns true; otherwise it returns false. You can find more about file_get_contents() and other file-related functions in 11. You can parse XML data in chunks if you prefer; this is useful if you have a lot of XML data and you d rather not read it all into memory in one go. To do this, just keep calling xml_parse() with the new chunk of data as the second argument. When passing the last chunk of data, pass a third value of true to xml_parse() to tell it that it s reached the end of the XML:
In comparison to the rectangular and elliptical marquee tools, the lasso tool provides a rather limited range of options. Generally speaking, you drag in a free-form path around the image you want to select. The few special considerations are as follows: Feathering and antialiasing: Just as you can feather rectangular and elliptical marquees, you can feather selections drawn with the lasso tool by selecting the Feather check box on the Options bar. To soften the edges of a lasso outline, select the Anti-aliased check box.
There are several ways that you can use APT. The most common is to use APT to install packages over the Internet. One function included with APT is the apt-get utility, which finds packages, resolves their dependencies, and installs them. You can also use APT on local files and CD-ROMs, however, with equally good results.
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