Download or read book Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics written by and published by . This book was released on 1987 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics written by Center for Drugs and Biologics and published by . This book was released on 1987 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics written by and published by . This book was released on 1988 with total page 76 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics written by and published by . This book was released on 1988 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Guideline for Submitting Documentation for the Manufacture of and Controls for Drug Products written by and published by . This book was released on 1987 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Regulatory Compliance Almanac written by Les Schnoll and published by Paton Professional. This book was released on 2008 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Federal Register written by and published by . This book was released on 1984-05 with total page 1068 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Peptide Therapeutics written by Ved Srivastava and published by Royal Society of Chemistry. This book was released on 2019-08-28 with total page 572 pages. Available in PDF, EPUB and Kindle. Book excerpt: Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development of novel peptide drugs in the clinic is their deficiencies in clearly defined chemistry, manufacturing and controls (CMC) strategy from clinical development to commercialization. CMC can often become a rate-limiting step due to lack of knowledge and lack of a formal policy or guidelines on CMC for peptide-based drugs. Regulators use a risk-based approach, reviewing applications on a case-by-case basis. Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing, and Controls covers efficient manufacturing of peptide drug substances, a review of the process for submitting applications to the regulatory authority for drug approval, a holistic approach for quality attributes and quality control from a regulatory perspective, emerging analytical tools for the characterisation of impurities, and the assessment of stability. This book is an essential reference work for students and researchers, in both academia and industry, with an interest in learning about CMC, and facilitating development and manufacture of peptide-based drugs.
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 Guidance for industry written by and published by . This book was released on 2002 with total page 2 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guideline for Submitting Samples and Analytical Data for Methods Validation written by and published by . This book was released on 1987 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Generic Drug Development Project Management written by Sandeep Narayan Patil, PMP and published by Notion Press. This book was released on 2021-04-17 with total page 281 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first book in the series of three. These three books will be based upon the idea to tailor PMI’s Project Management methodologies to the typical pharmaceutical projects. This book includes generic drug development project in detail. It is specially designed for Project Managers, team members and pharmacy students. Format of book is purposely kept simple. This book includes various useful flow charts and templates that can be used during the project life cycle. Information provided in this book is obtained from highly authentic sources, and links of data sources is provided for reference. Surely this is the kind of book every pharmaceutical personnel will want to be on their shelf.
Download or read book Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Download or read book Pharmaceutical Dosage Forms written by Kenneth E. Avis and published by Routledge. This book was released on 2018-05-04 with total page 565 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely updated and enlarged to three volumes (originally published as two volumes), the Second Edition of Pharmaceutical Dosage Forms: Parenteral Medications examines every important aspect of sterile drug products. This volume (3) offers comprehensive coverage of medical devices, quality assurance and regulatory issues.;This in-depth reference and text: discusses regulatory requirements in record-keeping based on the US Food and Drug Administration's (FDA) Current Good Manufacturing Practices; places special emphasis on methods of detecting, counting and sizing particles; offers new perspectives on contemporary validation concepts and how they affect the validation process; explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals; provides recent materials on the use of audits as a means of verifying the efficacy of manufacturing control systems; highlights new US regulations for medical devices; and examines quality assurance, including new information on biological control tests for medical device materials.;With the contributions of leading experts, volume 3 of Pharmaceutical Dosage Forms: Parenteral Medications is intended as a day-to-day reference for pharmacists, medical device manufacturers, quality control and regulatory personnel, chemists and drug patent and litigation attorneys, as well as a text for upper-level undergraduate, graduate and continuing-education students in the pharmaceutical sciences.
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 Vaccine Design written by Michael F. Powell and published by Springer. This book was released on 2012-12-06 with total page 977 pages. Available in PDF, EPUB and Kindle. Book excerpt: When my interest was first drawn to the phenomenon of vaccination for virus diseases in the late 1930s, the state of the art and the science of vaccine design was not far advanced beyond the time of Jenner at the end of the 18th century and of Pasteur a century later. In the 1930s it was still believed that for the induction of immunity to a virus-caused disease the experience of infection was required, but not for a toxin-caused disease such as diphtheria or tetanus, for which a chemically detoxified antigen was effective for immu nization. This prompted the question as to whether it might be possible to produce a similar effect for virus diseases using nonreplicating antigens. When in the 1930s and 1940s it was found possible to propagate influenza viruses in the chick embryo, protective effects could be induced without the need to experience infection by the use of a sufficient dose of a noninfectious influenza virus preparation. Later in the 1940s, it became possible to propagate polio and other viruses in cultures of human and monkey tissue and to immunize against other virus diseases in the same way. Later, with the advent of the era of molecular biology and genetic engineering, antigens and vaccines could be produced in new and creative ways, using either replicating or nonreplicating forms of the appropriate antigens for inducing a dose-related protective state.
