Books in Pharmaceutical quality control

1-10 of 17 results in All results

Health Literacy in Medicines Use and Pharmacy

• 1st Edition
• December 1, 2024
• Ahmed Awaisu + 4 more
• English
• Paperback 978-0-12-824407-4

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• eBook 978-0-323-85971-4

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Health Literacy in Medicines Use and Pharmacy: A Definitive Guide highlights issues related to medication literacy from the context of the pharmacist and other healthcare professionals. This definitive guide will undoubtedly serve as an invaluable resource for healthcare professionals in training and practice, fostering excellence in patient care globally. The book provides a clear explanation of medication literacy, presents different tools to assess health and medication literacy, readability, and comprehensibility of written medicine information (WMI), and elaborates on different approaches to develop customized and patient-friendly WMI. The book also covers health and medication literacy in special populations, including geriatrics, pediatrics, and pregnant/lactating patients. Written by experts in health communication, this book will help pharmacists, other health professionals, educators, students, and regulators, who need to develop customized educational materials that can be understood by a broad range of patients, especially those with low health literacy.

Fundamentals and Future Trends of 3D Printing in Drug Delivery

• 1st Edition
• December 1, 2024
• Dimitrios A. Lamprou + 1 more
• English
• Paperback 978-0-443-23645-7

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• eBook 978-0-443-23646-4

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Fundamentals and Future Trends of 3D Printing in Drug Delivery provides readers with all needed information for their journey from ideation to approval of innovative drug delivery devices produced through additive manufacturing.This book provides an in-depth discussion on key factors affecting the printing process such as different printer technologies, materials selection, resolutions, temperatures and speeds. Dedicated chapters include specific drug delivery devices in the form of oral solid dosage, implants, catheters and vascular grafts, and microneedles. The prospects of 3D printing associated with personalized medicine are covered in a full chapter.Fundamentals and Future Trends of 3D Printing in Drug Delivery is the perfect reference for any researcher or professional embarking on a 3D printing process for drug delivery devices. The regulatory aspects included are of particular interest to companies entering this promising market.

Biocontamination Control for Pharmaceuticals and Healthcare

• 2nd Edition
• January 28, 2024
• Tim Sandle
• English
• Paperback 978-0-443-21600-8

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• eBook 978-0-443-21601-5

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Biocontamination Control for Pharmaceuticals and Healthcare, Second Edition outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covers many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141), this new edition expands coverage of quality risk management and contains completely new examples to help professionals bridge the gap between regulation and implementation. This book offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy.

Computer-Aided Applications in Pharmaceutical Technology

• 2nd Edition
• September 7, 2023
• Jelena Duris
• English
• Hardback 978-0-443-18655-4

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• eBook 978-0-443-18656-1

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Computer-Aided Applications in Pharmaceutical Technology: Delivery Systems, Dosage Forms, and Pharmaceutical Unit Operations, Second Edition covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with an emphasis on their applications in process control, neural computing, data science, computer-aided biopharmaceutical characterization, as well as the application of computational fluid dynamics in pharmaceutical technology. Completely updated, the book introduces the theory and practice of computational tools through new case studies. Chapters cover Quality by Design in pharmaceutical development, overview data mining methodologies, present computer-aided formulation development, cover experimental design applications, and much more.

Evidence-Based Validation of Herbal Medicine

• 2nd Edition
• July 12, 2022
• Pulok K. Mukherjee
• English
• Paperback 978-0-323-85542-6

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• eBook 978-0-323-98456-0

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Evidence-Based Validation of Herbal Medicines: Translational Research on Botanicals brings together current thinking and practice in the characterization and validation of natural products. The book describes different approaches and techniques for evaluating the quality, safety and efficacy of herbal medicine, particularly methods to assess their activity and understand compounds responsible and their probable underlying mechanisms of action. This book brings together the views, expertise and experiences of scientific experts in the field of medicinal plant research, hence it will be useful for researcher who want to know more about the natural lead with their validation and also useful to exploit traditional medicines.

Regulatory Affairs in the Pharmaceutical Industry

• 1st Edition
• November 14, 2021
• Javed Ali + 1 more
• English
• Paperback 978-0-12-822211-9

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• eBook 978-0-12-822223-2

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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.

Remington

• 23rd Edition
• October 30, 2020
• Adeboye Adejare
• English
• Hardback 978-0-12-820007-0

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• eBook 978-0-12-822389-5

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The PCP's Bicentennial Edition Remington: The Science and Practice of Pharmacy, Twenty Third Edition, offers a trusted, completely updated source of information for education, training, and development of pharmacists. Published for the first time with Elsevier, this edition includes coverage of biologics and biosimilars as uses of those therapeutics have increased substantially since the previous edition. Also discussed are formulations, drug delivery (including prodrugs, salts, polymorphism. With clear, detailed color illustrations, fundamental information on a range of pharmaceutical science areas, and information on new developments in industry, pharmaceutical industry scientists, especially those involved in drug discovery and development will find this edition of Remington an essential reference. Intellectual property professionals will also find this reference helpful to cite in patents and resulting litigations. Additional graduate and postgraduate students in Pharmacy and Pharmaceutical Sciences will refer to this book in courses dealing with medicinal chemistry and pharmaceutics.

Pharmaceutical Quality by Design

• 1st Edition
• March 27, 2019
• Sarwar Beg + 1 more
• English
• Paperback 978-0-12-815799-2

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• eBook 978-0-12-816372-6

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Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process.

An Overview of FDA Regulated Products

• 1st Edition
• June 13, 2018
• Eunjoo Pacifici + 1 more
• English
• Paperback 978-0-12-811155-0

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• eBook 978-0-12-811156-7

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Approx.270 pages

CAPA in the Pharmaceutical and Biotech Industries

• 1st Edition
• December 8, 2015
• J Rodriguez
• English
• Hardback 978-1-907568-58-9

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• eBook 978-1-908818-37-9

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CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program contains the most current information on how to implement, develop, and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop process approach for medical devices and pharmaceutical and biologic manufacturers, as well as any anyone who has to maintain a quality system.This book addresses how companies often make the mistake of fixing problems in their processes by revising procedures or, more commonly, by retraining employees that may or may not have caused the problem. This event-focused fix leads to the false assumption that the errors have been eradicated and will be prevented in the future. The reality is that the causes of the failure were never actually determined, therefore the same problem will recur over and over. CAPA is a complete system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause of nonconformities. It is not just a quick-fix, simple approach, it is a process and has to be understood throughout organizations.