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Altus Pharmaceuticals Reports Dosing First Patient In A Phase 2 Trial Of ALTU-238 For Pediatric Growth Hormone Deficiency
Altus Pharmaceuticals Inc. (NASDAQ: ALTU) announced that patient dosing in its Phase 2 trial for ALTU-238 in growth hormone deficiency pediatric subjects began on June 2, 2009. ALTU-238 is a long-acting, extended-release formulation of recombinant human growth hormone (rhGH, somatropin), which is being developed utilizing Altus" proprietary protein crystallization technology. ALTU-238 is a ready-to-use liquid suspension of crystallized rhGH that preserves the structure of the rhGH molecule without the need for pegylation, polymerization, or encapsulation and enables administration through a fine gauge needle. The Phase 2 ALTU-238 pediatric trial is being conducted in approximately 18 clinical sites in the U.S. and targets enrolling 36 growth hormone deficient pediatric patients. ALTU-238 has been studied in a series of Phase 1 and Phase 2 studies in healthy and GH deficiency adults.
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Medication Quality In Peru And Region Strengthened With Official Laboratory's Accreditation

In an effort that will contribute to raising the quality of medicines in Peru and the surrounding region, the country"s National Center for Quality Control - the Centro Nacional de Control de Calidad (CNCC) - has attained internationally recognized ISO/IEC 17025:2005 accreditation for testing and calibration laboratories. This achievement is being celebrated today in Lima by the CNCC along with its partners who assisted the laboratory in achieving this accreditation, including the U.S. Agency for International Development (USAID) and the U.S. Pharmacopeial (USP) Convention, a scientific nonprofit organization that develops and disseminates standards for the identity, quality, purity, strength and consistency of medicines as well as dietary supplements and food ingredients. ACLASS, an accrediting body based in Washington, D.C., awarded CNCC the ISO/IEC accreditation for five key analytical tests. This accreditation certifies that CNCC is providing valid and trustworthy data to the Peruvian Ministry of Health, helping to ensure the distribution of good quality medicines to the country"s citizens. CNCC is one of only a few official medicines control laboratories in Latin America to have achieved this accreditation. "I congratulate the Ministry of Health and the CNCC on this tremendous achievement, which is the culmination of years of diligence and hard work," said Roger L. Williams, M.D., chief executive officer of USP. "The importance of this accreditation should not be understated. Patients and doctors should be able to trust that the medicines they take or administer are of high quality. The work we all do in helping to ensure that is the case is vital and life-saving. There is no better way to demonstrate commitment to quality than to submit oneself to the objective scrutiny of public quality standards such as those offered by ISO." "The ISO/IEC 17025:2005 accreditation positions CNCC as an international reference for labs working on quality control of pharmaceutical products. It consolidates our technical competitiveness, widens our reach and allows us to contribute to the sustainable development of Peru and the region in public health," said Dr. Ruben Tabuchi, CNCC general director. USP, through its Drug Quality and Information (DQI) Program, provided technical assistance to CNCC in a number of different capacities, including conducting an assessment of the CNCC laboratory"s quality management system against ISO/IEC standards; providing ongoing monitoring of CNCC"s progress toward accreditation; and hosting a CNCC intern at its U.S. headquarters to observe first hand how USP"s quality management system complies with ISO standards. The USP DQI Program has supported quality assurance and quality control systems in Peru through the USAID-funded Amazon Malaria Initiative since 2002 and South American Infectious Diseases Initiative since 2005, which work to improve malaria control and contain the spread of antimicrobial resistance, respectively. USAID is an independent agency that provides economic, development and humanitarian assistance around the world in support of the foreign policy goals of the United States. USP DQI is a cooperative agreement with USAID that works to improve drug quality in developing countries. The program focuses on the availability of high-quality medicines to treat life-threatening diseases including HIV/AIDS, malaria and tuberculosis. Lack of access to, and misuse of, these medications is a major public health threat throughout much of the world. Francine Pierson US Pharmacopeia


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