Download or read book La validation analytique dans le contr le des m dicaments et exemples d application written by Laurence Grinie and published by . This book was released on 2006 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: La validation des méthodes analytiques est un concept fondamental au sein des laboratoires de contrôle qualité de l'industrie pharmaceutique. Cette étape est essentielle afin d'une part, de se conformer aux exigences réglementaires, et, d'autre part, dans une approche qualité, de développer la maîtrise des méthodes d'analyse, au quotidien. Les exemples d'application, détaillés dans cette présentation, illustrent le déroulement, la place et l'importance de la validation analytique. La validation, de type initiale, d'une méthode de dosage est entreprise, après la phase de développement, afin de démontrer que cette méthode est réellement adaptée au dosage à réaliser. Les compléments de validation, effectués après évaluation des modifications apportées aux méthodes d'analyse au cours de leur usage, permettent de garantir la pérennité de ces méthodes.
Download or read book Place de la validation de m thodes analytiques dans le d veloppement de nouveaux m dicaments written by Mathilde Grolleau and published by . This book was released on 2016 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Validation analytique written by Isabelle Pinguet and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Le contrôle analytique avant libération d'un médicament sur le marché est une étape importante et nécessaire pour garantir la qualité du produit qui va être délivré aux patients. Les laboratoires pharmaceutiques sont tenus de prouver que les méthodes utilisées lors de ce contrôle sont parfaitement valides et fiables, en procédant à leur validation. L'utilisation du profil d'exactitude couplé à l'intervalle de tolérance comme outil de décision de validation est une méthode développée par une commission de la SFSTP parue en 2003 et en 2006 dans les guides STP Pharma Pratiques. Cet outil de décision permet de prévoir avec quelle garantie une proportion donnée des résultats futurs obtenus avec la méthode seront compris dans des limites d'acceptabilité fixées au préalable. Cette thèse propose une application pratique de la procédure publiée par la SFSTP en 2003 et 2006 utilisant le profil d'exactitude, à la validation analytique de produits aux caractéristiques bien spécifiques et jusqu'alors oubliés des guides de validation : les produits de phytothérapie, ou médicaments à base de plante(s).
Download or read book Syst me de revue des validations de m thodes analytiques written by Hugo Magrin and published by . This book was released on 2019 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Le contrôle qualité est un domaine indispensable des industries pharmaceutiques qui contribue à assurer la qualité, la sécurité et l'efficacité des médicaments mis sur le marché en s'inscrivant dans un système plus global d'assurance qualité. Les méthodes analytiques sont l'élément de base de ce domaine et permettent d'effectuer ces contrôles. Les validations analytiques permettent d'assurer que ces méthodes répondent correctement à leur attendu en routine. Elles s'inscrivent dans un contexte réglementaire très encadré. Cette réglementation et les technologies évoluant, il devient nécessaire pour les industriels d'entrer dans une appréciation plus approfondie des validations analytiques par l'évaluation périodique de ces validations (revue des validations). Actuellement, ces revues ne sont pas réglementées. Il convient par conséquent à l'industriel de les mettre en place en adéquation avec ses objectifs, la réglementation des validations analytiques et ses procédures internes. Ce document a pour objectif dans une première partie de recontextualiser la place des validations analytiques dans l'industrie pharmaceutique, ses prérequis réglementaires et de présenter les outils pour mettre en place une revue efficace sur un site. La seconde partie se veut être une présentation concrète d'un cas d'étude avec un exemple de mise en place d'une revue sur un site, la présentation de la méthodologie pour une revue individuelle et un exemple de plan associé.
Download or read book Gestion du cycle de vie des m thodes analytiques dans les laboratoires de contr le qualit written by Ho Mai Thy Nguyen and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: La gestion du cycle de vie analytique (ALCM) est un processus continu qui vise à évaluer et à améliorer la performance des méthodes analytiques. Son cycle de vie commence par l'identification du besoin jusqu'à la fin d'utilisation ou remplacement de la méthode. Ce processus garantit la maîtrise de la performance et de la conformité d'une méthode analytique durant toute sa période d'utilisation. Afin de prioriser la méthode analytique à optimiser, une analyse de risque est réalisée sur l'ensemble des méthodes analytiques mises en œuvre dans le laboratoire de contrôle qualité (CQ) en utilisant la méthode Risk Ranking and Filtering. Ainsi, le dosage du Polysorbate 80 (PS80) a été identifié comme une méthode à haut risque qui devait être optimisée. Afin de concevoir un plan d'action de correction pour réduire ce risque, tous les collaborateurs du projet ont répondu à une série de questions liées à la technique, via un formulaire, pour dégager les actions à mettre en place. Les résultats positifs obtenus par le laboratoire de développement des méthodes analytiques (Analytical Technical Support) seront ensuite appliqués au service CQ. L'efficacité des actions sera mesurée dans les années suivantes en réévaluant le score critique obtenu lors de l'analyse de risque ALCM pour ce test.
Download or read book Bases scientifiques et r glementaires de l valuation des m dicaments written by and published by . This book was released on 1980 with total page 814 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Some Antiviral and Antineoplastic Drugs and Other Pharmaceutical Agents written by IARC Working Group on the Evaluation of Carcinogenic Risks to Humans and published by World Health Organization. This book was released on 2000 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: Evaluates the carcinogenic risks to humans posed by the use of four antiretroviral agents four DNA topoisomerase II inhibitors used in the treatment of cancer and an additional three pharmaceutical agents (hydroxyures phenolphthalein and vitamin K substances). The volume marks the first IARC evaluation of nucleoside analogs that act as antiviral agents. The evaluation responds in part to recent findings that zidovudine (AZT) an effective antiretroviral agent now being given to pregnant HIV-infected women to prevent maternal-to-fetal transmission of the virus is a transplacental carcinogen in mice. The opening monograph evaluates the carcinogenicity to humans of the antiretroviral nucleoside analogs zidovudine (AZT) zalcitabine (ddC) and didanosine (ddI) and the antiherpesvirus drug aciclovir. Of these aciclovir and didanosine could not be classified on the basis of available data. For zidovudine transplacental administration to mice resulted in an increased incidence and multiplicity of lung and liver tumours and in an increased incidence of female reproductive tract tumours in one study but not in another involving treatment at a lower dose. Despite observation of toxic effects in some studies of humans human carcinogenicity data were judged to provide inadequate evidence of carcinogenicity in humans. Zidovudine was classified as possibly carcinogenic to humans. Similar weaknesses in human carcinogenicity data for zalcitabine which consistently induces thymic lymphomas in mice resulted in its classification as possibly carcinogenic to humans. The second monograph evaluates four DNA topoisomerase II inhibitors: etoposide teniposide mitoxantrone and amsacrine. Of these etoposide - one of the most widely used and effective cytotoxic drugs in combination therapy - was classified as probably carcinogenic to humans and etoposide in combination with cisplatin and bleomycin was judged to be carcinogenic to humans. Teniposide was classified as probably carcinogenic to humans and mitoxantrone and amsacrine were classified as possibly carcinogenic to humans. Of the three pharmaceutical agents evaluated in the final monograph hydroxyurea which is widely used in cancer treatment and increasingly in combination with didanosine in HIV infection could not be classified. Phenolphthalein a widely used laxative now being withdrawn from the market in many countries because of toxicological concerns was classified as possibly carcinogenic. Vitamin K substances could not be classified on the basis of available evidence.
Download or read book Qanuippitaa written by Louis Rochette and published by . This book was released on 2007-01-01 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book ICREEC 2019 written by Ahmed Belasri and published by Springer Nature. This book was released on 2020-06-10 with total page 659 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book highlights peer reviewed articles from the 1st International Conference on Renewable Energy and Energy Conversion, ICREEC 2019, held at Oran in Algeria. It presents recent advances, brings together researchers and professionals in the area and presents a platform to exchange ideas and establish opportunities for a sustainable future. Topics covered in this proceedings, but not limited to, are photovoltaic systems, bioenergy, laser and plasma technology, fluid and flow for energy, software for energy and impact of energy on the environment.
Download or read book Innovate Bristol written by Sven Boermeester and published by . This book was released on 2019-12 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovate Bristol highlights and celebrates those companies and individuals that are actively working at building a better tomorrow for all. Innovation Ecosystems thrive through the involvement and support of companies and individuals from all industries, which is why the Innovate series not only focuses on the innovators but also those people whom the Innovation Ecosystem, would not be able to thrive without.
Download or read book Chemical Analysis written by Francis Rouessac and published by John Wiley & Sons. This book was released on 2013-05-06 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated, Chemical Analysis: Second Edition is an essential introduction to a wide range of analytical techniques and instruments. Assuming little in the way of prior knowledge, this text carefully guides the reader through the more widely used and important techniques, whilst avoiding excessive technical detail. Provides a thorough introduction to a wide range of the most important and widely used instrumental techniques Maintains a careful balance between depth and breadth of coverage Includes examples, problems and their solutions Includes coverage of latest developments including supercritical fluid chromatography and capillary electrophoresis
Download or read book Predicting Structured Data written by Neural Information Processing Systems Foundation and published by MIT Press. This book was released on 2007 with total page 361 pages. Available in PDF, EPUB and Kindle. Book excerpt: State-of-the-art algorithms and theory in a novel domain of machine learning, prediction when the output has structure.
Download or read book Adjuvant Therapy for Breast Cancer written by Monica Castiglione and published by Springer Science & Business Media. This book was released on 2009-07-11 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adjuvant treatment is administered prior to or as follow up to surgical procedures for breast cancer. Proven success in using medical therapies allowing for breast conserving procedures or reducing risk of occurrence. Although there has been much progress towards a cure, including the introduction of new targeted therapies, metastasizing cancer remains highly incurable.
Download or read book A New Language for Psychoanalysis written by Roy Schafer and published by Yale University Press. This book was released on 1976-01-01 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: Should be of considerable interest to a wider public, since it proposes a radical reformulation of psychoanalytical theory which, if accepted, would render outmoded almost all the analytical jargon that has crept into the language of progressive, enlightened post-Freudian people.-Charles Rycroft, The New York Review of Books Schafer's arguments have considerable cogency. The tendency to over-theorize so that the translation of abstractions into the language of ordinary discourse between analyst and patient has become increasingly difficult is a fault; Schafer goes a long way towards redressing it, and his efforts to include meaning and the person in the form of his language is an achievement.-Michael Fordham, The Times Higher Education Supplement
Download or read book Biosocialities Genetics and the Social Sciences written by Sahra Gibbon and published by Routledge. This book was released on 2007-07-20 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biosocialities, Genetics and the Social Sciences explores the social, cultural and economic transformations that result from innovations in genomic knowledge and technology. This pioneering collection uses Paul Rabinow’s concept of biosociality to chart the shifts in social relations and ideas about nature, biology and identity brought about by developments in biomedicine. Based on new empirical research, it contains chapters on genomic research into embryonic stem cell therapy, breast cancer, autism, Parkinson’s and IVF treatment, as well as on the expectations and education surrounding genomic research. It covers four main themes: novel modes of identity and identification, such as genetic citizenship the role of institutions, ranging from disease advocacy organizations and voluntary organizations to the state the production of biological knowledge, novel life-forms, and technologies the generation of wealth and commercial interests in biology. Including an afterword by Paul Rabinow and case studies on the UK, US, Canada, Germany, India and Israel, this book is key reading for students and researchers of the new genetics and the social sciences – particularly medical sociologists, medical anthropologists and those involved with science and technology studies.
Download or read book An Introduction to Computational Learning Theory written by Michael J. Kearns and published by MIT Press. This book was released on 1994-08-15 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: Emphasizing issues of computational efficiency, Michael Kearns and Umesh Vazirani introduce a number of central topics in computational learning theory for researchers and students in artificial intelligence, neural networks, theoretical computer science, and statistics. Emphasizing issues of computational efficiency, Michael Kearns and Umesh Vazirani introduce a number of central topics in computational learning theory for researchers and students in artificial intelligence, neural networks, theoretical computer science, and statistics. Computational learning theory is a new and rapidly expanding area of research that examines formal models of induction with the goals of discovering the common methods underlying efficient learning algorithms and identifying the computational impediments to learning. Each topic in the book has been chosen to elucidate a general principle, which is explored in a precise formal setting. Intuition has been emphasized in the presentation to make the material accessible to the nontheoretician while still providing precise arguments for the specialist. This balance is the result of new proofs of established theorems, and new presentations of the standard proofs. The topics covered include the motivation, definitions, and fundamental results, both positive and negative, for the widely studied L. G. Valiant model of Probably Approximately Correct Learning; Occam's Razor, which formalizes a relationship between learning and data compression; the Vapnik-Chervonenkis dimension; the equivalence of weak and strong learning; efficient learning in the presence of noise by the method of statistical queries; relationships between learning and cryptography, and the resulting computational limitations on efficient learning; reducibility between learning problems; and algorithms for learning finite automata from active experimentation.
Download or read book The Nature of Statistical Learning Theory written by Vladimir Vapnik and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this book is to discuss the fundamental ideas which lie behind the statistical theory of learning and generalization. It considers learning as a general problem of function estimation based on empirical data. Omitting proofs and technical details, the author concentrates on discussing the main results of learning theory and their connections to fundamental problems in statistics. This second edition contains three new chapters devoted to further development of the learning theory and SVM techniques. Written in a readable and concise style, the book is intended for statisticians, mathematicians, physicists, and computer scientists.
