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Author : Jouni Vuorinen
Publisher :
ISBN 13 :
Total Pages : 122 pages
Book Rating : 4.F/5 ( download)
Download or read book A Stepwise Approach for Decision-making in Bioequivalence Studies written by Jouni Vuorinen and published by . This book was released on 1997 with total page 122 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : WHO Expert Committee on Biological Standardization. Meeting
Publisher : World Health Organization
ISBN 13 : 9241209771
Total Pages : 241 pages
Book Rating : 4.2/5 (412 download)
Download or read book WHO Expert Committee on Biological Standardization written by WHO Expert Committee on Biological Standardization. Meeting and published by World Health Organization. This book was released on 2013 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, endocrinological substances and in vitro diagnostic devices. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains revised WHO recommendations for production and control of live attenuated influenza vaccines and for production and control of pneumococcal conjugate vaccines. New WHO guidelines on the regulatory evaluation of similar biotherapeutic medicines are also provided. Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances.
Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 149874348X
Total Pages : 646 pages
Book Rating : 4.4/5 (987 download)
Download or read book Biosimilars and Interchangeable Biologics written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2018-10-30 with total page 646 pages. Available in PDF, EPUB and Kindle. Book excerpt: What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.
Author : Raymond Bertram
Publisher :
ISBN 13 : 9789512916986
Total Pages : 132 pages
Book Rating : 4.9/5 (169 download)
Download or read book Morphology in the Mind written by Raymond Bertram and published by . This book was released on 2000 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Aini-Kristiina Hartiala
Publisher :
ISBN 13 :
Total Pages : 256 pages
Book Rating : 4.F/5 ( download)
Download or read book Acquisition of Teaching Expertise in Content and Language Integrated Learning written by Aini-Kristiina Hartiala and published by . This book was released on 2000 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tiivistelmä.
Author : Anita Rubin
Publisher :
ISBN 13 :
Total Pages : 216 pages
Book Rating : 4.F/5 ( download)
Download or read book Growing Up in Social Transition written by Anita Rubin and published by . This book was released on 2000 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Mika Koivisto
Publisher :
ISBN 13 :
Total Pages : 130 pages
Book Rating : 4.F/5 ( download)
Download or read book Semantic Priming in the Cerebral Hemispheres written by Mika Koivisto and published by . This book was released on 1999 with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Christina Salmivalli
Publisher :
ISBN 13 :
Total Pages : 132 pages
Book Rating : 4.F/5 ( download)
Download or read book Not Only Bullies and Victims written by Christina Salmivalli and published by . This book was released on 1998 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Raija Portin
Publisher :
ISBN 13 :
Total Pages : 164 pages
Book Rating : 4.F/5 ( download)
Download or read book Cognitive Functioning in Midlife written by Raija Portin and published by . This book was released on 2000 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Janne Lepola
Publisher :
ISBN 13 :
Total Pages : 174 pages
Book Rating : 4.F/5 ( download)
Download or read book Motivation in Early School Years written by Janne Lepola and published by . This book was released on 2000 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Mika Hatakka
Publisher :
ISBN 13 :
Total Pages : 230 pages
Book Rating : 4.F/5 ( download)
Download or read book Novice Drivers' Risk- and Self-evaluations written by Mika Hatakka and published by . This book was released on 1998 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Päivi Hämäläinen
Publisher :
ISBN 13 :
Total Pages : 116 pages
Book Rating : 4.F/5 ( download)
Download or read book The Characteristics and Evolution of Incipient Cognitive Decline in Multiple Sclerosis written by Päivi Hämäläinen and published by . This book was released on 1998 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Laszlo Endrenyi
Publisher : CRC Press
ISBN 13 : 1498718809
Total Pages : 496 pages
Book Rating : 4.4/5 (987 download)
Download or read book Biosimilar Drug Product Development written by Laszlo Endrenyi and published by CRC Press. This book was released on 2017-02-24 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.
Author : Kaisa Lähteenmäki
Publisher : Turun Yliplisto
ISBN 13 :
Total Pages : 234 pages
Book Rating : 4.F/5 ( download)
Download or read book Globalization and Regionalization as Concurrent Phenomena in the European Governance Structure written by Kaisa Lähteenmäki and published by Turun Yliplisto. This book was released on 1999 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 0849383595
Total Pages : 602 pages
Book Rating : 4.8/5 (493 download)
Download or read book Handbook of Bioequivalence Testing written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2007-08-22 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made
Author : David B. Young
Publisher : Springer Science & Business Media
ISBN 13 : 1468460366
Total Pages : 299 pages
Book Rating : 4.4/5 (684 download)
Download or read book In Vitro-In Vivo Correlations written by David B. Young and published by Springer Science & Business Media. This book was released on 2013-03-08 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book represents the invited presentations and some of the posters presented at the conference entitled "In Vitro-In Vivo Relationship (IVIVR) Workshop" held in Sep tember, 1996. The workshop was organized by the IVIVR Cooperative Working Group which has drawn together scientists from a number of organizations and institutions, both academic and industrial. In addition to Elan Corporation, which is a drug delivery com pany specializing in the development of ER (Extended Release) dosage forms, the IVIVR Cooperative Working Group consists of collaborators from the University of Maryland at Baltimore, University College Dublin, Trinity College Dublin, and the University of Not tingham in the UK. The principal collaborators are: Dr. Jackie Butler, Elan Corporation Prof. Owen Corrigan, Trinity College Dublin Dr. lain Cumming, Elan Corporation Dr. John Devane, Elan Corporation Dr. Adrian Dunne, University College Dublin Dr. Stuart Madden, Elan Corporation Dr. Colin Melia, University of Nottingham Mr. Tom O'Hara, Elan Corporation Dr. Deborah Piscitelli, University of Maryland at Baltimore Dr. Araz Raoof, Elan Corporation Mr. Paul Stark, Elan Corporation Dr. David Young, University of Maryland at Baltimore The purpose of the workshop was to discuss new concepts and methods in the devel opment of in vitro-in vivo relationships for ER products. The original idea went back ap proximately 15 months prior to the workshop itself. For some time, the principal collaborators had been working together on various aspects of dosage form development.
Author : Isadore Kanfer
Publisher : Springer
ISBN 13 : 3319680781
Total Pages : 348 pages
Book Rating : 4.3/5 (196 download)
Download or read book Bioequivalence Requirements in Various Global Jurisdictions written by Isadore Kanfer and published by Springer. This book was released on 2017-12-05 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products.
