Principles of Parenteral Solution Validation

Produk Detail:
  • Author : Igor Gorsky
  • Publisher : Academic Press
  • Pages : 208 pages
  • ISBN : 0128094125
  • Rating : /5 from reviews
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Download or Read online Principles of Parenteral Solution Validation full in PDF, ePub and kindle. this book written by Igor Gorsky and published by Academic Press which was released on 15 April 2019 with total page 208 pages. We cannot guarantee that Principles of Parenteral Solution Validation book is available in the library, click Get Book button and read full online book in your kindle, tablet, IPAD, PC or mobile whenever and wherever You Like. Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. Discusses international and domestic regulatory considerations in every section Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation
  • Author : Igor Gorsky,Harold S. Baseman
  • Publisher : Academic Press
  • Release : 15 April 2019
GET THIS BOOK Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation
  • Author : Igor Gorsky,Harold S. Baseman
  • Publisher : Academic Press
  • Release : 27 November 2019
GET THIS BOOK Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges

Parenteral Medications Fourth Edition

Parenteral Medications  Fourth Edition
  • Author : Sandeep Nema,John D. Ludwig
  • Publisher : CRC Press
  • Release : 19 July 2019
GET THIS BOOK Parenteral Medications Fourth Edition

Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
  • Author : James P. Agalloco,Frederick J. Carleton
  • Publisher : CRC Press
  • Release : 25 September 2007
GET THIS BOOK Validation of Pharmaceutical Processes

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va

Handbook of Validation in Pharmaceutical Processes Fourth Edition

Handbook of Validation in Pharmaceutical Processes  Fourth Edition
  • Author : James Agalloco,Phil DeSantis,Anthony Grilli,Anthony Pavell
  • Publisher : CRC Press
  • Release : 29 October 2021
GET THIS BOOK Handbook of Validation in Pharmaceutical Processes Fourth Edition

Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of

Sterile Product Development

Sterile Product Development
  • Author : Parag Kolhe,Mrinal Shah,Nitin Rathore
  • Publisher : Springer Science & Business Media
  • Release : 12 October 2013
GET THIS BOOK Sterile Product Development

This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement

Principles of Fermentation Technology

Principles of Fermentation Technology
  • Author : Peter F Stanbury,Allan Whitaker,Stephen J Hall
  • Publisher : Butterworth-Heinemann
  • Release : 31 August 2016
GET THIS BOOK Principles of Fermentation Technology

The successful structure of the previous edition of Principles of Fermentation Technology has been retained in this third edition, which covers the key component parts of a fermentation process including growth kinetics, strain isolation and improvement, inocula development, fermentation media, fermenter design and operation, product recovery, and the environmental impact of processes. This accurate and accessible third edition recognizes the increased importance of animal cell culture, the impact of the post-genomics era on applied science and the huge contribution that

Disinfection and Decontamination

Disinfection and Decontamination
  • Author : Jeanne Moldenhauer
  • Publisher : CRC Press
  • Release : 20 November 2018
GET THIS BOOK Disinfection and Decontamination

This book describes various methods of decontamination and how the methods work. There is a discussion of the various cleaning and disinfection methods utilized, along with details of how to qualify these methods. It also describes new technologies that may be useful in the battle for decontamination across industries. Finally, this book provides a single resource on how one can address contamination issues for a variety of manufacturing processes and industries.

Principles and Practice of Multi Agent Systems

Principles and Practice of Multi Agent Systems
  • Author : Nirmit Desai,Alan Liu,Michael Winikoff
  • Publisher : Springer Science & Business Media
  • Release : 09 January 2012
GET THIS BOOK Principles and Practice of Multi Agent Systems

This book constitutes the thoroughly refereed post-conference proceedings of the 13th International Conference on Principles and Practice of Multi-Agent Systems, PRIMA 2010, held in Kolkata, India, in November 2010. The 18 full papers presented together with 15 early innovation papers were carefully reviewed and selected from over 63 submissions. They focus on practical aspects of multiagent systems and cover topics such as agent communication, agent cooperation and negotiation, agent reasoning, agent-based simulation, mobile and semantic agents, agent technologies for service computing, agent-based system development, ServAgents

Process Validation in Manufacturing of Biopharmaceuticals

Process Validation in Manufacturing of Biopharmaceuticals
  • Author : Anurag S. Rathore,Gail Sofer
  • Publisher : CRC Press
  • Release : 09 May 2012
GET THIS BOOK Process Validation in Manufacturing of Biopharmaceuticals

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in

Pharmaceutical Dosage Forms

Pharmaceutical Dosage Forms
  • Author : Sandeep Nema,John D. Ludwig
  • Publisher : CRC Press
  • Release : 26 August 2010
GET THIS BOOK Pharmaceutical Dosage Forms

Pharmaceutical Dosage Forms: Parenteral Medications explores the administration of medications through other than the enteral route. First published in 1984 (as two volumes) and then last revised in 1993, this three-volume set presents the plethora of changes in the science and considerable advances in the technology associated with these products