Download or read book GMP in Practice written by Vesper and published by David Horwood International Pub Limited. This book was released on 2000-07 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Medication Safety written by Molly Courtenay and published by Cambridge University Press. This book was released on 2009-10-01 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: The supply and administration of medicines is an area of practice in which a number of healthcare professionals (e.g. nurses, pharmacists and allied health professionals) are involved. Prescribing is a relatively new role which many of these healthcare professionals have adopted. Medication Safety focuses on promoting safety in the delivery of medicines. Chapters explore the various stages in the medication process including safety in prescribing, dispensing and administering drugs. Adverse reactions, parenteral administration, dosage calculations, safety with controlled drugs, and reporting errors and near misses are all addressed in evidence-based contributions from a highly experienced team of contributors. This text is essential reading for all healthcare professionals involved in the delivery of medicines to patients.
Download or read book Sterile Filtration written by Maik W. Jornitz and published by CRC Press. This book was released on 2020-04-15 with total page 640 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing practical applications of universal and dependable operational protocols, integrity testing, and troubleshooting to streamline the production and preparation of pharmaceuticals. Addresses the complexities of globalizing redundancy in filtration!
Download or read book Biotechnology from Idea to Market written by Fred Mermelstein and published by . This book was released on 2019-08 with total page 1026 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Extractables and Leachables written by Dennis Jenke and published by John Wiley & Sons. This book was released on 2022-08-02 with total page 468 pages. Available in PDF, EPUB and Kindle. Book excerpt: EXTRACTABLES AND LEACHABLES Learn to address the safety aspects of packaged drug products and medical devices Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these impurities must not adversely affect key quality attributes of the drug product or medical device, including its manufacturability, stability, efficacy, appearance, shelf-life and conformance to standards. Extractables and leachables are derived from the drug product’s packaging, manufacturing systems and/or delivery systems or from the medical device’s materials of construction. It is imperative to understand and quantify the release of extractables from these items, the accumulation of leachables in drug products and the release of leachables from medical devices. Once extractables and leachables have been discovered, identified and quantified, their effect on the key product or device quality attributes, including safety, must be systematically and scientifically established according to recognized, rigorous and relevant regulatory and compendial standards and industry-driven best practices. In Extractables and Leachables, the chemical compatibility (including safe use) of drugs (and their containers, delivery devices and manufacturing systems) and medical devices is examined at length, focusing particularly on how trace-level extractables and leachables affect the quality and safety of a medical product and how to assess the magnitude of the effect. This is accomplished by addressing the two critical activities required to develop, register and commercialize safe, effective and affordable clinical therapies; measuring extractables and leachables (chemical characterization) and assessing their impact (for example, toxicological safety risk assessment). Each of these activities is addressed in-depth, based on the existing and developing international regulations and guidelines, current published literature and the author’s extensive personal experience. Written by a key contributor to standards, guidelines, recommended practices and the scientific literature, the book provides “insider” insights beyond those gained by merely reading the relevant texts. Given that the rapidly evolving extractables and leachables landscape, this book provides the most current and crucial information on new and forthcoming regulations and best practices. Extractables and Leachables readers will also find: A thorough summary of regulatory and compendial guidelines and the steps required to meet them A detailed and in-depth review of essential scientific principles and recommended best practices for the design, implementation, interpretation and reporting of chemical characterization studies A practical resource for optimizing the development, registration, and commercialization of safe and effective medical products A helpful tool to maximize product development and successful regulatory outcomes Extractables and Leachables is the essential reference for pharmaceutical scientists, analytical chemists, regulatory affairs professionals, engineers, and toxicologists in areas such as product research and development, product registration and approval, regulatory affairs, analytical science, quality control, and manufacturing.
Download or read book Water activity applications in the pharmaceutical industry written by Anthony J. Fontana and published by . This book was released on 2009 with total page 291 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Practical Aseptic Processing written by Jack Lysfjord and published by Parenteral Drug Association. This book was released on 2009 with total page 405 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Martindale written by Sean C. Sweetman and published by . This book was released on 2006-01-01 with total page 3335 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is thirty-fifth edition of Martindale, which provides reliable, and evaluated information on drugs and medicines used throughout the world. It contains encyclopaedic facts about drugs and medicines, with: 5,500 drug monographs; 128,000 preparations; 40,700 reference citations; 10,900 manufacturers. There are synopses of disease treatments which enables identification of medicines, the local equivalent and the manufacturer. It also Includes herbals, diagnostic agents, radiopharmaceuticals, pharmaceutical excipients, toxins, and poisons as well as drugs and medicines. Based on published information and extensively referenced
Download or read book PDA Technical Report No 28 Revised 2006 written by PDA and published by . This book was released on 2006 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Prodrugs written by Valentino Stella and published by Springer Science & Business Media. This book was released on 2007-03-12 with total page 1447 pages. Available in PDF, EPUB and Kindle. Book excerpt: These volumes represent a comprehensive guide to prodrugs. They guide the reader through the current status of the prodrug concept and its many applications and highlight its many successes in overcoming formulation and delivery of problematic drugs. Replete with examples of approved and marketed prodrugs, these volumes introduce the topic to the novice as well as professional in the design of prodrugs.
Download or read book Cleaning Validation written by Destin A. LeBlanc and published by CRC Press. This book was released on 2022-12-23 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical manufacturers and upper management are encouraged to meet the challenges of the science-based and risk-based approaches to cleaning validation. Using some of the principles and practices in this volume will help in designing a more effective and efficient cleaning validation program. Features • Timely coverage of cleaning validation for the pharmaceutical industry, a dynamic area in terms of health-based limits. • The author encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and riskbased approaches to cleaning validation. • Draws on the author’s vast experience in the field of cleaning validation and hazardous materials. • Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for highly hazardous products in shared facilities. • A diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products.
Download or read book Phase Appropriate GMP for Biological Processes written by Trevor Deeks and published by . This book was released on 2018-04 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Long Acting Injections and Implants written by Jeremy C. Wright and published by Springer Science & Business Media. This book was released on 2012-01-29 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt: Long acting injections and implants improve therapy, enhance patient compliance, improve dosing convenience, and are the most appropriate formulation choice for drugs that undergo extensive first pass metabolism or that exhibit poor oral bioavailability. An intriguing variety of technologies have been developed to provide long acting injections and implants. Many considerations need to go into the design of these systems in order to translate a concept from the lab bench to actual therapy for a patient. This book surveys and summarizes the field. Topics covered in Long Acting Injections and Implants include the historical development of the field, drugs, diseases and clinical applications for long acting injections and implants, anatomy and physiology for these systems, specific injectable technologies (including lipophilic solutions, aqueous suspensions, microspheres, liposomes, in situ forming depots and self-assembling lipid formulations), specific implantable technologies (including osmotic implants, drug eluting stents and microfabricated systems), peptide, protein and vaccine delivery, sterilization, drug release testing and regulatory aspects of long acting injections and implants. This volume provides essential information for experienced development professionals but was also written to be useful for scientists just beginning work in the field and for others who need an understanding of long acting injections and implants. This book will also be ideal as a graduate textbook.
Download or read book Pharmaceutical Calculations written by Mitchell J. Stoklosa and published by . This book was released on 1986 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Practical Pharmaceutics written by Yvonne Bouwman-Boer and published by Springer. This book was released on 2015-08-24 with total page 873 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book contains essential knowledge on the preparation, control, logistics, dispensing and use of medicines. It features chapters written by experienced pharmacists working in hospitals and academia throughout Europe, complete with practical examples as well as information on current EU-legislation. From prescription to production, from usage instructions to procurement and the impact of medicines on the environment, the book provides step-by-step coverage that will help a wide range of readers. It offers product knowledge for all pharmacists working directly with patients and it will enable them to make the appropriate medicine available, to store medicines properly, to adapt medicines if necessary and to dispense medicines with the appropriate information to inform patients and caregivers about product care and how to maintain their quality. This basic knowledge will also be of help to industrial pharmacists to remind and focus them on the application of the medicines manufactured. The basic and practical knowledge on the design, preparation and quality management of medicines can directly be applied by the pharmacists whose main duty is production in community and hospital pharmacies and industries. Undergraduate as well as graduate pharmacy students will find knowledge and backgrounds in a fully coherent way and fully supported with examples.
Download or read book Pediatric Injectable Drugs written by Stephanie J. Phelps and published by . This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: For more than two decades, Pediatric Injectable Drugs (The Teddy Bear Book), has served an important and continuing need for reliable evidence-based information specific to pediatric injectable drugs. The tenth edition of this invaluable reference has grown to cover 238 drugs commonly used in the treatment of infants and children, including 20 new to this edition.
Download or read book Extended Stability for Parenteral Drugs written by Caryn M. Bing and published by . This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: When caring for patients, medication stability should be the least of your worries. Extended Stability for Parenteral Drugs, Fifth Edition, is the indispensable go-to reference for anyone working in alternate site infusion or preparing sterile compounds. This new edition will help you safely extend beyond-use dating of parenteral medications to minimize waste and reduce costs. What''s New in This Edition? � 160 updated monographs, including 10 new to this edition: o Acetaminophen o Ceftaroline fosamil o Coagulation Factor XIII o Doripenem o Ethanol lock o Ibuprofen o Pantoprazole o Telavancin o Toclizumab o Ziconotide acetate � 24 parenteral nutrition monographs include additional considerations for calcium and phosphate solubility. � Monograph updates include revisions to several container types and new information for elastometric infusion device brands. The Applying Stability Data in Patient Care section now includes a nursing perspective, a primer on the types of vascular access devices used in medication administration, and important considerations for pH, osmolality, concentration, and administration devices. With expanded tables and enhanced references, Extended Stability for Parenteral Drugs, Fifth Edition, is the only publication that brings key stability data on the most commonly used IV solutions, medications, and administration devices, together in one convenient, easy-to-use guide.
