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 : 2018-03-19
  • 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 ...

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 ...

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 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 ...

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 ...

Design of Experiments for Pharmaceutical Product Development

Design of Experiments for Pharmaceutical Product Development
  • Author : Sarwar Beg
  • Publisher : Springer Nature
  • Release Date : 2021-01-22
  • Total pages : 188
  • 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 ...

Advances and Challenges in Pharmaceutical Technology

Advances and Challenges in Pharmaceutical Technology
  • Author : Amit Kumar Nayak,Kunal Pal,Indranil Banerjee,Samarendra Maji,Upendranath Nanda
  • Publisher : Academic Press
  • Release Date : 2021-02-09
  • Total pages : 568
  • ISBN : 0128163720
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Summary : Advances and Challenges in Pharmaceutical Technology: Materials, Process Development and Drug Delivery Strategies examines recent advancements in pharmaceutical technology. The book discusses common formulation strategies, including the use of tools for statistical formulation optimization, Quality by design (QbD), process analytical technology, and the uses of various pharmaceutical biomaterials, including natural ...

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 ...

Computer Aided Pharmaceutics and Drug Delivery

Computer Aided Pharmaceutics and Drug Delivery
  • Author : Vikas Anand Saharan
  • Publisher : Springer Nature
  • Release Date : 2022-05-30
  • Total pages : 762
  • ISBN : 0128163720
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Summary : This book examines the role of computer-assisted techniques for discovering, designing, optimizing and manufacturing new, effective, and safe pharmaceutical formulations and drug delivery systems. The book discusses computational approaches, statistical modeling and molecular modeling for the development and safe delivery of drugs in humans. The application of concepts of QbD (...

Handbook of Pharmaceutical Granulation Technology

Handbook of Pharmaceutical Granulation Technology
  • Author : Dilip M. Parikh
  • Publisher : CRC Press
  • Release Date : 2021-05-12
  • Total pages : 904
  • ISBN : 0128163720
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Summary : This fully revised edition of Handbook of Pharmaceutical Granulation Technology covers the rapid advances in the science of agglomeration, process control, process modelling, scale-up, emerging particle engineering technologies, along with current regulatory changes presented by some of the prominent scientist and subject matter experts around the globe. Learn from more ...

Animal Cell Biotechnology

Animal Cell Biotechnology
  • Author : Hansjörg Hauser,Roland Wagner
  • Publisher : Walter de Gruyter GmbH & Co KG
  • Release Date : 2014-11-10
  • Total pages : 717
  • ISBN : 0128163720
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Summary : This book introduces fundamental principles and practical application of techniques used in the scalable production of biopharmaceuticals with animal cell cultures. A broad spectrum of subjects relevant to biologics production and manufacturing are reviewed, including the generation of robust cell lines, a survey of functional genomics for a better understanding ...