Download or read book Guideline for the Format and Content of the Chemistry Manufacturing and Controls Section of an Application written by and published by . This book was released on 1987 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Draft Guideline for the Format and Content of the Chemistry Manufacturing and Controls Section of an Application written by Center for Drugs and Biologics (U.S.) and published by . This book was released on 1985 with total page 9 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book International Pharmaceutical Product Registration written by Anthony C. Cartwright and published by CRC Press. This book was released on 2016-04-19 with total page 804 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.This cutting-edge resou
Download or read book Federal Register written by and published by . This book was released on 2018 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drug Development written by Charles E. Hamner and published by CRC Press. This book was released on 2019-06-12 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: Published in 1990: Overall the volume stands as a relatively comprehensive but not exhaustive summation of the complex process of drug development.
Download or read book NIDA Research Monograph written by and published by . This book was released on 1976 with total page 936 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Handbook of Pharmaceutical Granulation Technology written by Dilip M. Parikh and published by CRC Press. This book was released on 2021-05-11 with total page 905 pages. Available in PDF, EPUB and Kindle. Book excerpt: Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies
Download or read book Chemists Views of Imaging Centers written by Ali M. Emran and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: To continue the support for the growing trend of chemistry involvement in nuclear medicine, the Division of Nuclear Chemistry and Technology (DNCT) of the American Chemical Society (ACS) planned for a symposium to cover this aspect. This was expressed in arequest to me, as a member of the Program Committee, to organize a symposium on topics related to nuclear and radiochemistry applications to nuclear medicine. Realizing the growing interest in imaging, specially with positron emitting radioisotopes, I invited several colleagues to study with me the idea of imaging centers and the involvement of chemists in their structure and function. The formulated Organizing Committee supported this idea which evolved in proposing an extended international symposium to be held in conjunction with the 206th ACS National meeting in Chicago, Illinois, U. S. A. on August 22-27, 1993. The following are the members of the Organizing Committee: Jorge R. Barrio, Ph. D. Thomas E. Boothe, Ph. D. J. Robert Dahl, Ph. D. Robert F. Dannals, Ph. D. Bruce R. Erdal, Ph. D. Mark M. Goodman, Ph. D. George W. Kabalka, Ph. D. James F. Lamb, Ph. D. Ronald G. Manning, Ph. D. Henry C. Padgett, Ph. D. Roy S. Tilbury, Ph. D. Steven W. Yates, Ph. D. and Ali M. Emran, Ph. D.
Download or read book Generic Drug Product Development written by Leon Shargel and published by CRC Press. This book was released on 2013-10-24 with total page 397 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral
Download or read book New Drug Development written by Mark P. Mathieu and published by Omec. This book was released on 1987 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Handbook of Modern Pharmaceutical Analysis written by Satinder Ahuja and published by Academic Press. This book was released on 2010-11-11 with total page 604 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS
Download or read book Comprehensive Biotechnology written by and published by Elsevier. This book was released on 2019-07-17 with total page 4876 pages. Available in PDF, EPUB and Kindle. Book excerpt: Comprehensive Biotechnology, Third Edition, Six Volume Set unifies, in a single source, a huge amount of information in this growing field. The book covers scientific fundamentals, along with engineering considerations and applications in industry, agriculture, medicine, the environment and socio-economics, including the related government regulatory overviews. This new edition builds on the solid basis provided by previous editions, incorporating all recent advances in the field since the second edition was published in 2011. Offers researchers a one-stop shop for information on the subject of biotechnology Provides in-depth treatment of relevant topics from recognized authorities, including the contributions of a Nobel laureate Presents the perspective of researchers in different fields, such as biochemistry, agriculture, engineering, biomedicine and environmental science
Download or read book New Trends in Radiopharmaceutical Synthesis Quality Assurance and Regulatory Control written by Ali M. Emran and published by Springer Science & Business Media. This book was released on 2013-11-09 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: Marking the 200th National Meeting of the American Chemical Society, The Division of Nuclear Chemistry and Technology hosted a group of about 90 scientists from 15 different countries to discuss the new trends in radiopharmaceutical synthesis, quality assurance and regulatory control. This event took place in Washington, D.C. on August 27-30, 1990. When I first suggested the idea for this symposium, a group of scientists who pioneered the proposed topics offered their help to organize and run such a big task with me. Their names are listed here in appreciation. Thomas E. Boothe Cyclotron Facility, Mt. Sinai Medical Center, Miami Beach, Florida, USA Robert F. Dannals Division of Nuclear Medicine, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA Anthony L. Feliu Julich Nuclear Research Center, Julich, Germany Joanna S. Fowler Chemistry Department, Brookhaven National Laboratory, Upton, New York, USA George W. Kabalka Department of Chemistry, University of Tennessee, Knoxville, Tennessee, USA Hank F. Kung Department of Radiology, University of Pennsylvania, Philadelphia, Pennsylvania, USA James F. Lamb Imagents, Inc., Houston, Texas, USA Harold A. O'Brien, Jr. Los Alamos National Laboratory, Los Alamos, New Mexico, USA Joseph R. Peterson Dept. of Chemistry, University of Tennessee, Knoxville, Tennessee, USA Hernan Vera Ruiz International Atomic Energy Agency, Vienna, Austria Roy S. Tilbury University of Texas, M. D. Anderson Cancer Center, Houston, Texas, USA In addition, a number of distinguished colleagues have participated in the process of reviewing the manuscripts presented in this volume. Their effort is sincerely acknowledged.
Download or read book Pacific Yew Draft Environmental Impact Statement appendices written by and published by . This book was released on 1993 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt: Item no. 0080-F.
Download or read book New Drug Approval Process written by Richard A. Guarino and published by Marcel Dekker. This book was released on 1987 with total page 456 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Ansel s Pharmaceutical Dosage Forms and Drug Delivery Systems written by Loyd Allen and published by Lippincott Williams & Wilkins. This book was released on 2014-01-30 with total page 810 pages. Available in PDF, EPUB and Kindle. Book excerpt: Long established as a trusted core text for pharmaceutics courses, this gold standard book is the most comprehensive source on pharmaceutical dosage forms and drug delivery systems available today. Reflecting the CAPE, APhA, and NAPLEX® competencies, Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems covers physical pharmacy, pharmacy practice, pharmaceutics, compounding, and dosage forms, as well as the clinical application of the various dosing forms in patient care. This Tenth Edition has been fully updated to reflect new USP standards and features a dynamic new full color design, new coverage of prescription flavoring, and increased coverage of expiration dates.
Download or read book Biosimilarity written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2018-10-03 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: Summary: The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of immunogenicity. An in-depth scientific, mathematical and statistical view of the tools required to establish biosimilarity of biological drugs of different complexity -- a must for every developer of biosimilars. Features: First comprehensive analysis based on new guidelines and approval packages of several biosimilars Presents the first approach to challenge FDA in reducing or eliminating any testing in patients. Provides a comprehensive understanding of the U.S. statutory requirements vis-a-vis the regulatory guidelines Provides model CQA and Analytical Similarity testing protocols for cytokines and monoclonal antibodies Allow creation of a fast-to-market pathway to develop biosimilars
