Challenges Faced During eCTD and CTD Filling Procedures for USFDA and Canada

Electronic Common Technical Document (eCTD) is a topic of increasing interest in the pharmaceutical Industry as it become compulsory for filing procedures.  The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States.Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Electronic common technical documentis an interface used by applicants of marketing authorisation for medical products to submit regulatory affairs document to the agency concerned. The purpose of this article is to present a concise overview of challenges faced during eCTD & CTD submissions in United States and Canada. A regulatory process, by which a person/organization/ sponsor/innovator gets authorization to launch a drug in the market, is known as registration process. The registration process will be done by submitting technical information to the authority Keywords: electronic common technical document (ECTD)/ (CTD), International conference on hormonisation (ICH), Drug registration process

Nanomedicine Clinical Use, Regulatory and Toxicology Issues in Europe

Nano medicine is a revolutionizing field that can benefit both diagnosis and treatment and contribute to a better quality of life. Despite the expected huge benefits, the potential risks on human health are significant as well. This thesis aims to defense a perspective that in case of nascent technologies, where the data are still emerging and scientific uncertainty prevails, risk governance should sustain the process of scientific knowledge by developing guidelines, codes of conduct and public information and provide a minimum level of safety acceptable to protect human health. Although Nano medicine is at an early stage of development some cautious measures should be taken that will provide regulatory mechanisms able to respond to the challenges posed by Nano medicine, establish a minimum level of safety but will also allow the further promotion of scientific knowledge. This multidisciplinary approach can contribute in adopting regulatory choices and tools that will help manage the risks, protect human health and promote scientific knowledge.  As the technologies are designed based on a clear understanding of a particular disease, disease specific oriented focus is required for the development of novel pharmaceuticals. In addition, it will be important to establish a case-by-case approach to clinical and regulatory evaluation of each Nano pharmaceutical. High priority should be given to enhancing communication and exchange of information among academia, industry and regulatory agencies encompassing all facets of this multidisciplinary approach. Keywords: novel pharmaceuticals, Nano pharmaceuticals, toxicological issues, clinical use, Nano medicine

Use of hyghly reactive rice husk ash in the production of cement matrix reinforced with Green coconut fiber

[EN] This study evaluated the influence of partial replacement of Portland cement by rice husk ash (RHA) to enable the use of green coconut husk fiber as reinforcement for cementitious matrix. The use of highly reactive pozzolanic ash contributes for decreasing the alkaline attack on the vegetable fiber, originated from waste materials. The slurry dewatering technique was used for dispersion of the raw materials in aqueous solution, followed by vacuum drainage of water and pressing for the production of pad composites, as a simplified simulation of the Hatschek process for industrial manufacture. Five formulations were evaluated, two of them without any mineral additions. One of the mixtures served as a reference (without green coconut fibers) and the remaining ones were reinforced with the green coconut fibers (5% by weight of binder) and with the content of Portland cement replacement by RHA equal to 0, 30, 40 and 50%. The composites were analyzed at 28 days of age and after aging by immersion in warm wáter (65 ◦C), which lasted for 28 additional days. Physical and mechanical tests were applied for assessment of the performance of composites. Thermogravimetric analysis was used to observe the consumption of portlandite and chemically combined water content in the hydrated products for pastes presenting the same levels of Portland cement replacement by RHA (i.e., 0 50%) and with the water/binder ratio kept constant and equal to 0.5. The mechanical performance evaluated by bending test after 28 days reached the MOR of 15.7 MPa after the accelerate aging, for the composites reinforced with the green coconut fiber and with high levels of Portland cement replacement by RHA demonstrating that the use of Green coconut fiber for reinforcement can be very promising for the production of binary cement based matrix. The thermogravimetry showed that the replacement of Portland cement by the RHA helped in maintaining the mechanical behavior of the green coconut fiber in the composite subjected to the accelerated aging tests, and resulted in improved mechanical performance, providing a lightweight composite.To the Fundacao de Amparo Pesquisa do Estado de Sao Paulo (FAPESP) for financial support and ICITECH Universitat Politecnica de Valencia for facilitating the research development. To the Federal Agency CNPq, Brazil for grants provided to the USP team. Project 3018/2009 financed by Generalitat Valenciana, COMBURES project financed by Centro de Cooperacion al Desarrollo de la Universitat Politecnica de Valencia (ADSIDEO COOPERACIO) and Maicerias Espanolas DACSA S.A. for supplying RHA samples.Pereira, C.; Savastano, HJ.; Paya Bernabeu, JJ.; Santos, SF.; Borrachero Rosado, MV.; Monzó Balbuena, JM.; Soriano Martínez, L. (2013). Use of hyghly reactive rice husk ash in the production of cement matrix reinforced with Green coconut fiber. Industrial Crops and Products. 49:88-96. https://doi.org/10.1016/j.indcrop.2013.04.038S88964

Query Processing Issues in Image(multimedia) Databases

Multimedia databases have attracted academic and industrial interest, and systems such as QBIC (Content Based Image Retrieval system from IBM) have been released. Such systems are essential to effectively and efficiently use the existing large collections of image data in the modern computing environment. The aim of such systems is to enable retrieval of images based on their contents. This problem has brought together the (decades old) database and image processing communities. As part of our research in this area, we are building a prototype CBIR system called CHITRA. This uses a four level data model, and we have defined a Fuzzy Object Query Language(FOQL) for this system. This system enables retrieval based on high level concepts, such as "retrieve images of MOUNTAINS", "retrieve images of MOUNTAINS and SUNSET". A problem faced in this system is processing of complex queries such as "retrieve all images that have similar color histogram AND similar texture to the given example imag..

A Performance Study of Hashing Functions for Hardware Applications

Hashing is used extensively in hardware applications such as page tables for address translation. There is not much literature in this regard although hashing has been extensively studied for file organization. More specifically, there is no study of the practical performance of hashing functions used. In the literature we find bit extraction and exclusive ORing hashing functions used, but there is no mention of the performance of these functions. Moreover, the performance of the hashing functions in relation to the theoretical performance of hashing schemes is not addressed. In this paper we study the practical performance of a particular class of hashing functions. Our results show that by choosing functions randomly from this class of hashing functions, which can be readily implemented in hardware, we can achieve analytically predicted performance of hashing schemes with real life data. 1622 1 Introduction Hashing is a widely used technique of organizing tables which also finds ..

Electrochemical studies on electrospun Li(Li 1/3Ti 5/3)O 4 grains as an anode for Li-ion batteries

10.1016/j.electacta.2012.01.099Electrochimica Acta6733-40ELCA