Pharmaceutical Quality by Design

Written By Sarwar Beg
Pharmaceutical Quality by Design
  • Publsiher : Academic Press
  • Release : 27 March 2019
  • ISBN : 0128163720
  • Pages : 448 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled Pharmaceutical Quality by Design written by Sarwar Beg which was release on 27 March 2019, this book published by Academic Press. Available in PDF, EPUB and Kindle Format. Book excerpt: 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. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design
  • Author : Sarwar Beg,Md Saquib Hasnain
  • Publisher : Academic Press
  • Release Date : 2019-03-27
  • Total pages : 448
  • ISBN : 0128163720
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Summary : 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 ...

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design
  • Author : Walkiria S. Schlindwein,Mark Gibson
  • Publisher : John Wiley & Sons
  • Release Date : 2018-01-05
  • Total pages : 368
  • ISBN : 0128163720
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Summary : A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD ...

Pharmaceutical Quality by Design Using JMP

Pharmaceutical Quality by Design Using JMP
  • Author : Rob Lievense
  • Publisher : SAS Institute
  • Release Date : 2018-10-03
  • Total pages : 436
  • ISBN : 0128163720
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Summary : Solve your pharmaceutical product development and manufacturing problems using JMP . Pharmaceutical Quality by Design Using JMP : Solving Product Development and Manufacturing Problems provides broad-based techniques available in JMP to visualize data and run statistical analyses for areas common in healthcare product manufacturing. As international regulatory agencies push the concept of ...

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
  • Author : Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz
  • Publisher : John Wiley & Sons
  • Release Date : 2017-09-01
  • Total pages : 416
  • ISBN : 0128163720
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Summary : Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD ...

Quality by Design for Biopharmaceuticals

Quality by Design for Biopharmaceuticals
  • Author : Anurag S. Rathore,Rohin Mhatre
  • Publisher : John Wiley & Sons
  • Release Date : 2011-09-20
  • Total pages : 312
  • ISBN : 0128163720
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Summary : The concepts, applications, and practical issues of Quality byDesign Quality by Design (QbD) is a new framework currently beingimplemented by the FDA, as well as EU and Japanese regulatoryagencies, to ensure better understanding of the process so as toyield a consistent and high-quality pharmaceutical product. QbDbreaks from past approaches in ...

Handbook of Analytical Quality by Design

Handbook of Analytical Quality by Design
  • Author : Sarwar Beg,Md Saquib Hasnain,Mahfoozur Rahman,Waleed H. Almalki
  • Publisher : Academic Press
  • Release Date : 2021-01-09
  • Total pages : 222
  • ISBN : 0128163720
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Summary : Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed ...

Quality by Design for Biopharmaceutical Drug Product Development

Quality by Design for Biopharmaceutical Drug Product Development
  • Author : Feroz Jameel,Susan Hershenson,Mansoor A. Khan,Sheryl Martin-Moe
  • Publisher : Springer
  • Release Date : 2015-04-01
  • Total pages : 710
  • ISBN : 0128163720
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Summary : This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters ...

How to Integrate Quality by Efficient Design QbED in Product Development

How to Integrate Quality by Efficient Design  QbED  in Product Development
  • Author : Bhavishya Mittal
  • Publisher : Academic Press
  • Release Date : 2019-08-24
  • Total pages : 274
  • ISBN : 0128163720
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Summary : The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical ...

Pharmaceutical Quality Assurance

Pharmaceutical Quality Assurance
  • Author : Mr. Manohar A. Potdar
  • Publisher : Pragati Books Pvt. Ltd.
  • Release Date : 2006
  • Total pages : 420
  • ISBN : 0128163720
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Summary : Download or read online Pharmaceutical Quality Assurance written by Mr. Manohar A. Potdar, published by Pragati Books Pvt. Ltd. which was released on 2006. Get Pharmaceutical Quality Assurance Books now! Available in PDF, ePub and Kindle....

Computer Aided Applications in Pharmaceutical Technology

Computer Aided Applications in Pharmaceutical Technology
  • Author : Jelena Djuris
  • Publisher : Elsevier
  • Release Date : 2013-04-10
  • Total pages : 300
  • ISBN : 0128163720
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Summary : Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially available products. Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods. Simultaneous development and ...

Design of Experiments for Pharmaceutical Product Development

Design of Experiments for Pharmaceutical Product Development
  • Author : Sarwar Beg
  • Publisher : Springer Nature
  • Release Date : 2021-01-12
  • Total pages : 96
  • ISBN : 0128163720
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Summary : This book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development. It discusses the applications of experimental designs that shall include oral, topical, transdermal, injectables preparations, and beyond for nanopharmaceutical product development, leading to ...

Nanoformulation Strategies for Cancer Treatment

Nanoformulation Strategies for Cancer Treatment
  • Author : Sarwar Beg,Mahfoozur Rahman,Hani Choudhry,Eliana B. Souto,Farhan J. Ahmad
  • Publisher : Elsevier
  • Release Date : 2020-11-20
  • Total pages : 402
  • ISBN : 0128163720
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Summary : Nanoformulation Strategies for Cancer Treatment provides an up-to-date review on current developments and regulatory and clinical challenges in the field of nanopharmaceuticals and the effective treatment of diverse varieties of cancer. This important reference source is ideal for biomaterials scientists and pharmaceutical scientists working in the area of cancer diagnosis ...

Computer Applications in Drug Discovery and Development

Computer Applications in Drug Discovery and Development
  • Author : Puratchikody, A.,Prabu, S. Lakshmana,Umamaheswari, A.
  • Publisher : IGI Global
  • Release Date : 2018-11-23
  • Total pages : 332
  • ISBN : 0128163720
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Summary : With more restrictions upon animal experimentations, pharmaceutical industries are currently focusing on a new generation of experiments and technologies that are considerably more efficient and less controversial. The integration of computational and experimental strategies has led to the identification and development of promising compounds. Computer Applications in Drug Discovery and ...

Methodologies in Biosimilar Product Development

Methodologies in Biosimilar Product Development
  • Author : Sang Joon Lee,Shein-Chung Chow
  • Publisher : CRC Press
  • Release Date : 2021-09-30
  • Total pages : 392
  • ISBN : 0128163720
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Summary : Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the mix-up use of interval hypotheses testing (i.e., the use of TOST) ...

Liposomes

Liposomes
  • Author : Angel Catala
  • Publisher : BoD – Books on Demand
  • Release Date : 2019-09-04
  • Total pages : 102
  • ISBN : 0128163720
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Summary : Liposomes have received increased attention in recent years. Nevertheless, liposomes, due to their various forms and applications, require further investigation. These structures can deliver both hydrophilic and hydrophobic drugs. The preparation of liposomes results in different properties for these systems. In addition, there are many factors and difficulties that affect ...