Set Of Standard Procedures Research Articles

Induced traffic and economic appraisal

Economic appraisal of major roads in the UK is based on a set of standard procedures and conventions. A central assumption has been that the volume and pattern of traffic in any given year is independent of the quality of service offered by the network — the fixed trip matrix assumption. Failing to consider induced traffic can have serious consequences for the accuracy and robustness of the measured traffic benefits from road improvements. Assessment of the wider economic benefits of roads, which is an important political imperative for road investment, is also made more difficult. Two conclusions are reached. Variable trip matrix methods need to be introduced for the appraisal of major road schemes, and scheme appraisal needs to be complemented by a more strategic area-wide approach to evaluation. In responding to its advisory committee (SACTRA), the UK Department of Transport has accepted the first of these conclusions and is cautiously favourable to the second.

Regulatory affairs and biotechnology in Europe. I. Introduction into good regulatory practice.

The high cost and risks associated with the research and development of new drugs demand an alert as well as realistic legislative policy at both national and international levels. Registration of a new drug required before a marketing license is granted, is important for all branches of the pharmaceutical industry but is crucial for success in the innovative biotechnological sector. Innovation as such is no guarantee to be profitable. Increasing government demands have introduced uncertainty on whether new products will secure registration and have led to a disproportionate increase in the economical risks for innovative industry. Preparation and submission of an application for registration should be undertaken seriously and professionally since it has significantly more consequences than simply obtaining a marketing licence. It will influence marketing strategies and results. It is proposed--since dealing with regulatory affairs can be considered as an essential specialism--to apply a Quality Assurance approach. Activities in this context should comply with the same performance standards as developed for GMP, GLP and GCP leading to Good Regulatory Practice (GRP). By acknowledging regulatory affairs as a quality assurance means one can define a set of standard procedures within an organization to ensure that decisions are made on current and future regulations. In such a setup regulatory affairs becomes a marketing tool. This paper illustrates the complex problems found in registration activities. It underlines the necessity of introducing a GRP-approach of performance resulting in substantive evidence of regulatory efficacy.

Use of Membrane Filters for Microscopic Preparations of Sponge Spicules

A new method for preparation of sponge spicules for microscopy utilizes membrane filters for separation of spicules from cleaning fluids. The membranes with adherent spicules are cleared during mounting on microscope slides for direct analysis by light microscopy. The basic filtration procedure is also used to produce preparations for scanning electron microscopy. The main advantages of this procedure over a variety of traditional methods include preclusion of spicule loss during cleaning and significant reduction of procedure-introduced variation. The technique described offers promise for quantitative analysis of spicule complements. Incentive to develop a standardized procedure for spicule preparation stems from several problems noted in publications of both veteran and neophyte sponge taxonomists. Most prevalent is a general absence of detailed reporting of methods employed in spicule examinations. The result is a disturbing lack of certainty in taxonomic identifications, deriving partly from real differences in the specimens themselves, but also is an artifact of the methods of spicule preparation and analysis. The most commonly reported problems are the rare occurrence or absence of a spicule type and differences in size of spicules from specimens that otherwise appear to belong to the same species. We surveyed 123 primary taxonomic papers on Porifera published during the last 40 years3. Although the sample is biased by both ease of access and language of publication (untranslated Eastern languages were excluded), it does include all of the important contemporary treatments: 75% (n = 92) of these papers include no mention of the method of skeletal preparation; 19% (n = 24) include a short mention of, or reference to, a technique; and only 6% (n = 7) provide a description of methods in sufficient detail to enable duplication. Potential investigators looking to these publications of methods to use in identification, and, more importantly, seeking an authoritative format for preparation of taxonomic publications, are provided with little or no guidance. A detailed set of standard procedures for (1) making spicule preparations, (2) examining them microscopically, and (3) carrying out and reporting quantitative statistical analyses on the data generated has not been formally proposed or tested. Our purpose is to put forward a basic procedure for producing permanent spicule preparations. This procedure is new, requires minimal speSupported by a Natural Sciences and Engineering Research Council of Canada Operating Grant

GRASP—A 3D graphics system for Pascal users

This paper describes a 3D graphics package ‘GRASP’ implemented in Pascal language and interfaced with the Pascal compiler developed for the DEC PDP-10 machine, by Urs Amman et al. GRASP supports storage tube and raster scan graphics terminals and pen plotters. The package is incorporated as a set of standard procedures into the enhanced Pascal compiler. The various features of the package are presented here and a comparison is made vis-a-vis the other existing 3D graphics packages. GRASP is simple to use and provides a valuable tool for the development of application programs written in Pascal and requiring a graphics capability.

Cell-cell interactions in conjugating Escherichia coli: Con− mutants and stabilization of mating aggregates

Conjugation-deficient (Con-) mutants of Escherichia coli K-12 have been previously described which were defective in recipient ability. Such Con- mutants were obtained from several laboratories and retested by a standardized set of procedures. Many of the mutants did not satisfy minimal criteria for conjugation-deficiency and were discarded. The remaining mutants included 11 ConF- mutants mutated in or near the ompA cistron, 3 ConF- mutants synthesizing a heptose-deficient lipopolysaccharide and 1 ConI- mutants synthesizing a defective lipopolysaccharide. This set of mutants was tested for resistance to a variety of bacteriophages and colicins; the only phenotype fully correlated with the ConF- phenotype was that of resistance to colicin L. No simple correlation existed between the protein profile (on SDS polyacrylamide gel electrophoresis) of cell envelope outer membrane preparations and conjugation deficiency. However, many ConF- mutants did not synthesize detectable levels of outer membrane protein II* and protein II* may have been nonfunctional in the remainder. All the ConF- mutants were conjugation-deficient when matings were conducted in liquid but (with one exception) were conjugation-proficient on the surfaces of membrane filters. None of the ConF- mutants formed stable mating aggregates in liquid with (Flac)+ donor cells although all bound purified F pili. The ConF- phenotype associated with a II*-deficient recipient could be mimicked by the addition of purified protein II* (solubilized with lipopolysaccharide). In both cases, the formation of stable mating aggregates (analyzed with an improved Coulter counter technique) was inhibited whereas unstable mating aggregates were detected by electron microscopy. F pilus and wall to wall contacts were both observed under these conditions by electron microscopy. These results were used to define a stage in F-promoted conjugation, the stabilization stage, which requires the functional interaction of protein II* and lipopolysaccharide in the outer membrane of the recipient cell.

Real Time Languages for Process Control

The Central Instrument Research Laboratory of Imperial Chemical Industries installed a Ferranti Argus 400 in 1966 for the control of multiple laboratory experiments. An operating system was devised and implemented by Cobb, Magee, and Williams (1967); the main purpose of this system was to provide each of several users with a pseudo multi-processor capability with storage protection from other users (see also Magee, 1970). The technique evolved by Cobb to provide storage protection by software in the absence of any assistance from the hardware involved the effective interpretation of all dynamic store and branch instructions in the users programs; these instructions were then costly in space and time. It is against the background of this operating system that the development of SML (Barnes, 1969), the laboratory's first attempt at a real time high level language, must be seen. SML (Small Machine Language) was a simple variant of ALGOL but with static storage allocation. It included a scaled fixed point facility in addition to the normal ALGOL types. Multi-tasking was provided via a set of standard procedures (activate, delay, waitfor, etc.) essentially as proposed by Benson, Cunningham, Currie, Griffiths, Kingslake, Long, and Southgate (1967). Normal ALGOL parameter mechanism was provided; this parameter mechanism was re-entrant but coding was otherwise not re-entrant except inasmuch that individual procedures could be executed in parallel. A compiler to translate SML text into Ferranti Argus Initial Orders Mk 3 was written in KDF9 ALGOL and programs were originally thus compiled off-line. The compiler was later rewritten in itself and bootstrapped to provide an on-line compiler. Experiences with SML on experimental plant in the author's laboratory were entirely successful (Brisk, Davies, and Jones, 1969); subsequently the language was also used for programming the control software of production plant (Garside, Gow, and Perkins, 1969). In the latter case, however, the operating system itself needed considerable modification and being written in an assembly language this was a non-trivial exercise. This earlier work provided the background to a new project whose objectives are to develop a language/compiler/package system for general use in process control and similar on-line applications. It was decided to undertake this project in stages, the language RTL/1, whose description now follows, is the result of the first stage.