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Good Manufacturing Practices for Pharmaceuticals, Seventh Edition
This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.
Good Laboratory Practice for Nonclinical Studies
The GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry. This book provides a unique opportunity to access interpretation of the 21CFR58 regulatory requirements from leading industry experts with a vast knowledge and expertise in their fields. The approach used takes the regulations, provides interpretations and references to examples and regulatory actions. Data integrity and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures are also discussed. • Unique volume covering FDA inspections of GLP facilities • Provides a detailed interpretation of GLP Regulations • Presents the latest on electronic data management in GLP • Describes GLP and computer systems validation • Can be referenced repeatedly in supporting daily hands on implementation of the CFR requirements
Good Clinical Practices in Pharmaceuticals
Good clinical practice (GCP) is a set of internationally recognized ethical and scientific quality requirements that must be followed when designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with GCP assures patients and the public that the rights, safety, and wellbeing of people taking part in studies are protected and that research data is reliable. Presents details on GCP, the international ethical, scientific, and practical standard to which all clinical research is conducted. Provides the most up‐to‐date and best practices, techniques, and methodologies in good clinical practice. Discusses applicable laws and regulations supporting GCP compliance, quality and operations. Describes who is responsible for implementing and maintaining quality assurance and quality control systems to ensure that studies are conducted and data are generated, documented, and reported in compliance with the protocol.
Patient Safety in Developing Countries
Understanding the various aspects of patient safety education, practice, and research in developing countries is vital in preparing a plan to overcome the challenges of improving patient safety. This unique volume discusses patient safety in developing countries, and the achievements and challenges faced in those places when trying to improve patient safety education and practice.This book includes a compilation of over 100 case studies surrounding patient safety in all aspects of health care. Both real and simulated scenarios are provided to help medical students and professionals apply their knowledge to solve the cases and prepare for real practice. Features Describes the achievements and challenges of patient safety in developing countries Includes real and simulated case studies and key answers on patient safety issues Prepares medical students and practitioners for real-life situations Diverse audience including those in medication to safety testing, patient education, dispensing changes, and the design of health systems Aids medical students and practitioners to improve their skills to solve cases
Cancer Targeting Therapies
This volume in the popular series, Drugs and the Pharmaceutical Sciences, begins with the history of cancer treatment, carcinogens, and molecular mechanisms involved in cancer pathogenesis. It incudes conventional and advanced cancer therapies ranging from oral and parenteral preparations to advanced fabricated systems such as nanoparticles, liposomes, antibodies, aptamers, poly(amidoamine) and photodynamic therapies. The preparation and mechanisms of molecular targeting of cancer are presented and the authors focus on a diverse audience including undergraduates and research students. Features Timely coverage of changes in process control technology for the phamaceutical industry, a dynamic ...
GMP Audits in Pharmaceutical and Biotechnology Industries
The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authori...
An Introduction to Generative Drug Discovery
This book focuses on the latest advances in computational de novo drug discovery methods, also known as generative drug discovery. This book describes the state‐of‐the‐art methods and applications for de novo design of drug candidates using generative chemistry models as well as the ethical aspects of this technology. It will provide a foundation for those new to the field as well as those that may already have some experience of its utility. With contributions from scientists in both academia and industry ‘an Introduction to Generative Drug Discovery’ may represent one of the earliest if not the first book to focus on this topic. This book focuses on the latest advances in generative discovery methods. This book will describe different state of the art applications of generative molecule design. The book describes ethical aspects of generative drug discovery technology. The mix of academic and industrial authors provides an array of applications of generative drug discovery. A future perspective of where these generative technologies may take us in drug discovery is described included self-driving labs.
Gene Delivery Systems
This unique volume in our Drugs and Pharmaceutical Sciences series covers the development of gene therapy today, the technology involved, clinical applications of siRNA, non-viral vector-based mRNA delivery using nanotechnology, and RNA based vaccines for treating the infectious diseases. It also presents the current application of the CRISPR/Cas9 gene-editing technique which has revolutionized genome editing and which was awarded the 2020 Nobel Prize in Chemistry. Several new drug delivery systems are explored for the applications of gene therapy. These are found to be useful in treating chronic illnesses, including cancer and infectious diseases. Key Features: Overview of the development of gene therapy Provides the most up to date information on the development of gene therapy, from the technology involved to gene correction and genome editing Presents CRISPR gene therapy recent trends and applications Discusses siRNA, mRNA, and DNA plasmids
Emerging Drug Delivery and Biomedical Engineering Technologies
This book details the advances in drug discovery and delivery and the present need for emerging technologies. Throughout the text new micro and nanofabrication techniques are described, including methods such as electrohydrodynamic processes, additive manufacturing, and microfluidics, which have the potential to produce drug delivery systems that were not possible a few years ago. This book is of great use to both entry-level and experienced researchers in the field of emerging technologies for the manufacturing of drug delivery devices. Features: Describes technologies that are significantly enhancing the delivery of drugs and biologics Presents new data on mobile and wearable point-of-care testing systems Features hot topics such as electrospinning, 3D printing and micro-needles Focuses on additive manufacturing (AM) which can be used to provide customized treatment for patients Will appeal to experienced researchers and those considering entering the field of emerging technologies for the manufacturing of drug delivery devises
Good Manufacturing Practices for Pharmaceuticals
With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.
