Guidance Index
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Guidance Index
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Author :
language : en
Publisher:
Release Date : 1950
Guidance Index written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1950 with Vocational guidance categories.
Information Sheets
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Author :
language : en
Publisher:
Release Date : 1998
Information Sheets written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998 with Drugs categories.
A Laboratory Quality Handbook Of Best Practices
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Author : Donald C. Singer
language : en
Publisher: Quality Press
Release Date : 2001-09-25
A Laboratory Quality Handbook Of Best Practices written by Donald C. Singer and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-09-25 with Business & Economics categories.
Based on the work of a collection of experts from the laboratory science and quality assurance fields, A Laboratory Quality Handbook of Best Practices and Relevant Regulations provides all of the information needed to run a successful laboratory that is in compliance with all regulations. From sample tracking to accurate documentation, training to methods validation, maintenance to calibration, and out-of-spec responses to preparation for audits, a combination of people, instrumentation and documentation must work in sync for high quality results. This handbook provides information that will help a laboratory achieve high quality results and compliance. Contents: Quality Assurance in the Laboratory, History of Regulation, Training in the Laboratory, Laboratory Documentation and Data, Sample Control and LIM Systems, Methods Validation
Inorganic Controlled Release Technology
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Author : Xiang Zhang
language : en
Publisher: Butterworth-Heinemann
Release Date : 2015-08-28
Inorganic Controlled Release Technology written by Xiang Zhang and has been published by Butterworth-Heinemann this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-08-28 with Science categories.
Inorganic Controlled Release Technology: Materials and Concepts for Advanced Drug Formulation provides a practical guide to the use and applications of inorganic controlled release technology (iCRT) for drug delivery and other healthcare applications, focusing on newly developed inorganic materials such as bioresorbable glasses and bioceramics. The use of these materials is introduced for a wide range of applications that cover inorganic drug delivery systems for new drug development and the reformulation of existing drugs. The book describes basic concepts, principles, and industrial practices by discussing materials chemistry, physics, nano/microstructure, formulation, materials processing, and case studies, as well as the evaluation and characterization of iCRT systems commonly investigated during industrial R&D. - Provides the first book on inorganic controlled release technology (iCRT), covering key aspects from chemistry, physics, synthetic methods, formulation design, characterization and evaluation - Includes several industry-related case studies to provide practical guidance on how to use iCRT as an alternative to organic polymers systems for both future drug developments and other active ingredient applications - Demonstrates how iCRT offers an unmet business need for improved, controlled release of actives versus traditional CRT systems, which are known to have difficulty with the controlled delivery of both poorly and highly water soluble drug compounds
New Drug Development
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Author : Chandrahas Sahajwalla
language : en
Publisher: CRC Press
Release Date : 2004-05-24
New Drug Development written by Chandrahas Sahajwalla and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-05-24 with Medical categories.
Highlighting key points from the latest regulatory requirements, New Drug Development helps those new to the world of pharmaceutical development understand regulatory steps, reduce cost by avoiding unnecessary trials, and attain guidance through each step of the drug approval process. This volume acquaints readers with procedures that determine the
Excipient Development For Pharmaceutical Biotechnology And Drug Delivery Systems
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Author : Ashok Katdare
language : en
Publisher: CRC Press
Release Date : 2006-07-28
Excipient Development For Pharmaceutical Biotechnology And Drug Delivery Systems written by Ashok Katdare and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-07-28 with Medical categories.
To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new, yet to be developed, and approved excipients continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge potential new avenues for regulatory approval. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.
Pharmaceutical Manufacturing Handbook
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Author : Shayne Cox Gad
language : en
Publisher: John Wiley & Sons
Release Date : 2008-04-04
Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-04-04 with Science categories.
With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
Handbook Of Biogeneric Therapeutic Proteins
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Author : Sarfaraz K. Niazi
language : en
Publisher: CRC Press
Release Date : 2002-08-15
Handbook Of Biogeneric Therapeutic Proteins written by Sarfaraz K. Niazi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-08-15 with Medical categories.
More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulato
Regulatory Delivery
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Author : Graham Russell
language : en
Publisher: Bloomsbury Publishing
Release Date : 2019-10-17
Regulatory Delivery written by Graham Russell and has been published by Bloomsbury Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-10-17 with Law categories.
This ground-breaking book addresses the challenge of regulatory delivery, defined as the way that regulatory agencies operate in practice to achieve the intended outcomes of regulation. Regulatory reform is moving beyond the design of regulation to address what good regulatory delivery looks like. The challenge in practice is to operate a regulatory regime that is both appropriate and effective. Questions of how regulations are received and applied by those whose behaviour they seek to control, and the way they are enforced, are vital in securing desired regulatory outcomes. This book, written by and for practitioners of regulatory delivery, explains the Regulatory Delivery Model, developed by Graham Russell and his team at the UK Department for Business, Energy and Industrial Strategy. The model sets out a framework to steer improvements to regulatory delivery, comprising three prerequisites for regulatory agencies to be able to operate effectively (Governance Frameworks, Accountability and Culture) and three practices for regulatory agencies to be able to deliver societal outcomes (Outcome Measurement, Risk-based Prioritisation and Intervention Choices). These elements are explored by an international group of experts in regulatory delivery reform, with case studies from around the world. Regulatory Delivery is the first product of members of the International Network for Delivery of Regulation.
Preclinical Development Handbook
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Author : Shayne Cox Gad
language : en
Publisher: John Wiley & Sons
Release Date : 2008-03-21
Preclinical Development Handbook written by Shayne Cox Gad and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-03-21 with Medical categories.
A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic,comprehensive reference to prioritizing and optimizing leads, toxicity, pharmacogenomics, modeling, and regulations. This single definitive, easy-to-use resource discusses all the issues that need consideration and provides detailed instructions for current methods and techniques. Each chapter was written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * In vitro mammalian cytogenetics tests * Phototoxicity * Carcinogenicity studies * The pharmacogenomics of personalized medicine * Bridging studies * Toxicogenomics and toxicoproteomics Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This is a hands-on guide for pharmaceutical scientists involved in preclinical testing,enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.