Download or read book Good Manufacturing Practices for Pharmaceuticals written by Joseph D. Nally and published by CRC Press. This book was released on 2016-04-19 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book GMP Compliance Productivity and Quality written by Vinay Bhatt and published by CRC Press. This book was released on 1998-06-30 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by twenty-eight experts, filled with recommendations that can immediately be put into action, this book provides the strategies and tactics required to link and harmonize manufacturing processes with GMP to achieve optimum operability and cost-effective regulatory compliance. Drawn from name brand and generic companies and regulatory and contract organizations across the globe, the contributing authors bring readers a combined 450+ years of hands-on experience. They offer thought-provoking questions to help readers diagnose their company's challenges, needs, and available options, all with the single purpose of achieving their ultimate goals: quality, high productivity, and profitability.

Download or read book Compliance Handbook for Pharmaceuticals Medical Devices and Biologics written by Carmen Medina and published by CRC Press. This book was released on 2003-12-09 with total page 604 pages. Available in PDF, EPUB and Kindle. Book excerpt: This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.

Download or read book Pharmaceutical Process Scale Up written by Michael Levin and published by CRC Press. This book was released on 2001-12-12 with total page 588 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focusing on scientific and practical aspects of process scale-up, this resource details the theory and practice of transferring pharmaceutical processes from laboratory scale to the pilot plant and production scale. It covers parenteral and nonparenterel liquids and semi-solids, products derived from biotechnology, dry blending and powder handling,

Download or read book Statistical Design and Analysis of Stability Studies written by Shein-Chung Chow and published by CRC Press. This book was released on 2007-05-30 with total page 351 pages. Available in PDF, EPUB and Kindle. Book excerpt: The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how sta

Download or read book Industrial Pharmacy written by Dr Muralidhar, Dr Narmada and published by Notion Press. This book was released on 2024-02-03 with total page 281 pages. Available in PDF, EPUB and Kindle. Book excerpt: Industrial Pharmacy: From Pilot Plant to Market" is a comprehensive guide that provides practical approaches to pharmaceutical product development. With 37 exhaustive chapters, it covers important topics such as pilot plant scale-up techniques, technology transfer protocols, regulatory requirements, quality management systems, and Indian regulatory requirements. The book helps readers understand the significance of personnel requirements, space requirements, raw materials, and relevant documentation for solids, liquid orals, and semi-solids. It also provides insights into WHO guidelines for technology transfer, clinical research protocols, quality management concepts, ISO quality systems standards, and Indian regulatory requirements. This book is an essential resource for pharmaceutical professionals and students who seek to advance healthcare through innovative pharmaceutical product development.

Download or read book Handbook of Stability Testing in Pharmaceutical Development written by Kim Huynh-Ba and published by Springer Science & Business Media. This book was released on 2008-11-16 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.

Download or read book Federal Register written by and published by . This book was released on 2013-04 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book FDA Regulatory Affairs written by Douglas J. Pisano and published by CRC Press. This book was released on 2008-08-11 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in

Download or read book Statistics in Drug Research written by Shein-Chung Chow and published by CRC Press. This book was released on 2002-02-20 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the safety and efficacy of pharmaceutical compounds. Cove

Download or read book A Textbook of INDUSTRIAL PHARMACY II written by Yogesh Kumar , Mrs. Shaheen , Dr. T Yunus Pasha , Mrs. Anjali Mishra, Dr. Minal Narkhede and published by Shashwat Publication. This book was released on 2024-07-20 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introducing the book "Industrial Pharmacy-II" is something that fills me with an incredible amount of joy. The content of this book has been meticulously crafted to adhere to the curriculum for Bachelor of Pharmacy students that has been outlined by the Pharmacy Council of India. An effort has been made to investigate the topic using terminology that is as straightforward as possible in order to make it more simply digestible for pupils. The book has a number of illustrations, such as flowcharts and diagrams that make it simple for students to comprehend complex ideas. It is the author's honest desire that both students and academicians would take something helpful away from reading this book.

Download or read book Dosage Form Design Considerations written by and published by Academic Press. This book was released on 2018-07-28 with total page 881 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. - Examines the history and recent developments in drug dosage forms for pharmaceutical sciences - Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism - Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Download or read book Encyclopedia of Clinical Pharmacy written by Joseph T. DiPiro and published by CRC Press. This book was released on 2012-11-04 with total page 958 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Encyclopedia of Clinical Pharmacy is a valuable resource for today's clinical pharmacist and pharmacotherapist. Over 200 researchers and practitioners provide ready access to more than 5,000 primary literature citations and hard-to-find research on: Gene therapy Health service delivery models Best practices documents Pharmaceutical software development Legal controversies, ethical issues, and court rulings Drug dosing and electronic prescription Post-marketing surveillance Generic equivalency Quality management procedures Educational and training programs Compiling expertise and recommendations from the American College of Clinical Pharmacy and the American Society of Health-System Pharmacists, the Encyclopedia unravels the increasing complexity of pharmacotherapy, the problems of medication-related morbidity and mortality, and the impact that clinically empowered pharmacists have on assuring safe and effective pharmaceutical care for patients.

Download or read book Pharmaceutical Dosage Forms written by Larry L. Augsburger and published by CRC Press. This book was released on 2017-10-30 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Dosage Forms: Capsules covers the development, composition, and manufacture of capsules. Despite the important role that capsules play in drug delivery and product development, few comprehensive texts on the science and technology of capsules have been available for the research and academic environments. This text addresses this gap, discussing how capsules provide unique capabilities and options for dosage form design and formulation.

Download or read book Handbook of Pharmaceutical Granulation Technology written by Dilip M. Parikh and published by CRC Press. This book was released on 2016-04-19 with total page 678 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Third Edition presents all pharmaceutical industry personnel and those in academia with critical updates on the recent advances in granulation technology and changes in FDA regulatory guidelines. Addressing precisely how these recent innovations and revisions affect unit operation of particle generation and granulation, this text assists the re

Download or read book Applications of Pharmacokinetic Principles in Drug Development written by Rajesh Krishna and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume is an important advancement in the application ofpharmacokinetic (PK) and pharmacodynamic (PO) principles to . drug development. The series of topics presented deal with the application of these tools to everyday decisions that a pharmaceutical scientist encounters. The ability to integrate these topics using PK and PO methods has optimized drug development pathways in the clinic. New technologies in the areas of in vitro assays that are more predictive of human absorption and metabolism and advancement in bioanalytical assays are leading the way to minimize drug failures in later, more expensive clinical development programs. of Pharmacokinetics and pharmacodynamics have become an important component understanding the drug action on the body and is becoming increasingly important in drug labeling due to it's potential for predicting drug behavior in populations that may be difficult to study in adequate numbers during drug development. The ability to correlate drug exposure to effect and model it during the drug development value chain provides valuable insight into optimizing the next steps to derive maximum information from each study. These principles and modeling techniques have resulted in an expanded and integrated view of PK and PO and have led to the expectations that we may be able to optimally design clinical trials and eventually lead us to identifying the optimal therapy for the patient, while minimizing cost and speeding up drug development. There is wide utility for the book both as a text and as a reference.

Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-04-04 with total page 857 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.