Stability Testing of Clinical Samples

The stability program for clinical samples as presented is based on the ICH Tripartite Guideline for Stability Testing of New Drug Substances and Products and the same principles that the program followed throughout the development of a drug product. But the Guideline and the basic principles were adapted to deal with the specific problems encountered with clinical samples. The expiration dates represent minimum shelf lives, storage conditions, and storage periods, and the minimum shelf lives correspond the duration of the clinical trials in phases I to III. Shelf lives are established on the basis of stress and accelerated tests to provide all batches with an open expiration date. They are supported and confirmed by long-term tests conducted under the storage conditions presenting climate zone II, 25°C/60% RH. The self lives determined apply to all the batches of the relevant development stage, although only the batches in the final phase of development originate from a validated manufacturing phase. For different dosages, dosage forms, and packaging materials, the number of batches and analysis is reduced by scientifically based rationalization measures such as bracketing and matrixing. The stability results obtained with clinical samples are a major factor for achieving a comprehensive assessment of the quality of a finished medicinal product. In this way it is possible to establish a link between the quality of clinical batches for phases I-III and the quality of the finished drug product.     

An overview of FDA medical device regulation as it relates to deep brain stimulation devices.

The United States Food and Drug Administration (FDA) is charged with assuring the safety and effectiveness of a variety of medical products and the FDA's Center for Devices and Radiological Health is responsible for premarket and postmarket regulation of medical devices. In this paper, we review--from device classification and clinical studies to the final marketing application--FDA's premarket requirements and postmarket requirements as they relate to deep brain stimulation devices.     

宽幅数码印刷机亮相IPEX 2002

当数码印刷、种类繁多的承印物以及经过改进的覆膜技术为印制精美耐用的户内、户外广告招贴的应用开辟了一条新的道路,建立了一种宽渠道的盈利模式时,宽幅印刷已经走向     

Interhemispheric transfer after spontaneous recovery in 43 cases of severe closed head injury.

Examined the possibility of frequent callosal disconnection following closed head injury. Interhemispheric transfer was evaluated in 43 severe closed-head-injured patients (aged 18–51 yrs) using a wide-ranging battery of untimed behavioral tasks, after the period of spontaneous recovery. Only 1 S showed signs of callosal disconnection. Much effective interhemispheric transfer occurred in closed-head-injured Ss after the period of spontaneous recovery. More frequent occurrence of the disconnection syndrome in its acute phase is a possibility that cannot be excluded. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

The UCLA Multidimensional Condom Attitudes Scale: Documenting the complex determinants of condom use in college students.

Describes the development and validation of the UCLA Multidimensional Condom Attitudes Scale (MCAS). The relationships between the MCAS and gender, sexual experience, intentions to use a condom, and past condom use were assessed. The MCAS has 5 distinct factors: (1) Reliability and Effectiveness of condoms, (2) the sexual Pleasure associated with condom use, (3) the stigma attached to persons who use condoms (Identity Stigma), (4) the Embarrassment About Negotiation and Use of condoms, and (5) the Embarrassment About the Purchase of condoms. Results strongly suggest that condom attitudes are multidimensional and thus cannot meaningfully be summed to a single global score. Results further indicate that men and women hold very different attitudes toward condoms. Implications of scale multidimensionality and directions for future research are discussed. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Surface designing of polypropylene by critical monitoring of the grafting conditions

The grafting of acrylic acid onto electron beam‐irradiated polypropylene was carried out using preirradiation method. The stability of peroxy radicals was investigated by electron spin resonance. It was found that the decay of peroxy radicals is much faster at 70°C than at 40°C and ambient temperature. The grafting has been observed to be strongly dependent on the monomer dilution in the reaction medium. The grafting was ascertained by attenuated total reflectance (ATR). The distribution of grafts across the samples was monitored by infrared microscopy. It was found that the graft management is considerably influenced by composition of the grafting medium. The grafting involving pure monomer leads to the surface enrichment with the polyacrylic acid chains. The samples grafted in pure monomer led to much lower contact angles as compared to the diluted monomer solution. The swelling of the grafted samples also showed a trend that was governed by the graft management. © 2006 Wiley Periodicals, Inc. J Appl Polym Sci 100: 546–553, 2006     

Highly integrated direct conversion receiver for GSM/GPRS/EDGE with on-chip 84-dB dynamic range continuous-time /spl Sigma//spl Delta/ ADC

This paper describes a highly digitized direct conversion receiver of a single-chip quadruple-band RF transceiver that meets GSM/GPRS and EDGE requirements. The chip uses an advanced 0.25-/spl mu/m BiCMOS technology. The I and Q on-chip fifth-order single-bit continuous-time sigma-delta (/spl Sigma//spl Delta/) ADC has 84-dB dynamic range over a total bandwidth of /spl plusmn/135 kHz for an active area of 0.4 mm/sup 2/. Hence, most of the channel filtering is realized in a CMOS IC where digital processing is achieved at a lower cost. The systematic analysis of dc offset at each stage of the design enables to perform the dc offset cancellation loop in the digital domain as well. The receiver operates at 2.7 V with a current consumption of 75 mA. A first-order substrate coupling analysis enables to optimize the floor plan strategy. As a result, the receiver has an area of 1.8 mm/sup 2/.     

Bridging the generation gap between text planning and linguistic realization

Text planning is traditionally done as a separate process, independent of linguistic realization. However, I show in this paper that it is essential for a text planner to know the linguistic consequences of its actions. The choice of how to realize an element affects how much information is conveyed (e.g., “Floyd arrived safely in Boston” vs. “Floyd landed safely at Logan”) and what other information can be added (e.g., “Peter was deciding for an hour” vs. *“Peter made a decision for an hour”). The choice of realization also affects how the relative salience of the elements being expressed will be perceived (e.g., “The green car is in the garage” vs. “The car in the garage is green”). I have defined an intermediate level of representation for text planning, called the Text Structure. It is an abstract linguistic level that reflects germane linguistic constraints while abstracting away from syntactic detail. This representation allows the text planner to have greater control over the decisions, so that it can take advantage of the expressiveness of language to convey subtleties of meaning. More importantly, the Text Structure allows the generation process overall to be incremental, since it ensures that the text plan being composed will always be expressible in the language. La planification de textes est habituellement réalisée séparément, sans tenir compte de la réalisation linguistique. Cependant, ľauteur demontre dans cet article qu'il est essentiel à un planificateur de textes de connai̊tre les conséquences linguistiques de ses actions. Le choix de la méhode de réalisation ?un élément influe sur la quantité?informations qui est transmise (par ex.: 〈〈 Floyd est arrivé sain et sauf à Boston 〉〉 et 〈〈 Floyd a atterri sain et sauf àľaéroport Logan 〉〉) et sur quelle autre information peut ětre ajoutée. Le choix de la méthode de réalisation influe également sur la façon dont les caractères saillants des ééments qui sont exprimés seront perçus (par ex.: 〈〈 la voiture verte est dans le garage 〉〉 et 〈〈 la voiture dans le garage est verte 〉〉). L'auteur a défini un niveau intérmediaire de représentation pour la planification de textes qu'il a appelé structure de texte. Il; s'agit ?'un niveau linguistique abstrait qui refléte les contraintes linguistiques appropriées tout en s'éloignant du détail syntaxique. Cette représentation permet au planificateur de textes ?avoir un meilleur contrǒle des décisions, et done de tirer profit de la force ?expression du langage afin de tenir compte des subtiliés de sens. Plus important encore, la structure de texte permet au processus de génération ?ětre incrémentiel, car elle s'assure que le plan de texte en voie de composition soit toujours exprimable dans le langage.     

Multihour engineering and traffic routing optimization in hierarchical telephone networks

Classical hierarchical routing in telephone networks is extended to a wider class called out-of-chain routing in such a way that some useful properties of hierarchical routing are retained. This new routing pattern offers more potential paths than the fixed hierarchical one and can be introduced as a dynamic routing where the fixed alternate sequences change at some predetermined instants during the day. The effect of this new routing pattern on the network performances is examined. The main topic of this paper is to present heuristic methods used to optimise such routings in large networks. We show on artificial networks that the throughput of a given network can be significantly improved by suitable routing choices. We demonstrate that the integration of routing changes within a multihour dimensioning process is possible but the lack of realistic data does not permit at this time to quantify the value of routing optimization on real networks.     

Linguistic Knowledge, Processing Speed, and Metacognitive Knowledge in First- and Second-Language Reading Comprehension: A Componential Analysis.

The authors report results of a study into the role of components of first-language (L1; Dutch) and second-language (L2; English) reading comprehension. Differences in the contributions of components of L1 and L2 reading comprehension are analyzed, in particular processing speed in L1 and L2. Findings indicate that regression weights of the L1 and L2 components are different. Although correlations between most processing speed components and reading comprehension are substantial, there are no unique contributions to the explanation of either L1 or L2 reading comprehension when linguistic and metacognitive knowledge are accounted for. In addition, L1 reading comprehension is shown to have a large contribution to L2 reading comprehension, supporting theories of L1-L2 transfer of reading skills. Results are discussed from a developmental perspective. (PsycINFO Database Record (c) 2010 APA, all rights reserved)