Pharmaceutical Drug Product Development And Process Optimization

Pharmaceutical Drug Product Development and Process Optimization PDF
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Author: Sarwar Beg
Publisher: CRC Press
ISBN: 1000731588
Size: 18.96 MB
Format: PDF, ePub, Mobi
Category : Business & Economics
Languages : en
Pages : 382
View: 7270

Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.


Pharmaceutical Drug Product Development And Process Optimization

Pharmaceutical Drug Product Development and Process Optimization PDF
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Author: Sarwar Beg
Publisher: CRC Press
ISBN: 1000731324
Size: 68.23 MB
Format: PDF, Kindle
Category : Business & Economics
Languages : en
Pages : 354
View: 5417

Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.


Design Of Experiments For Pharmaceutical Product Development

Design of Experiments for Pharmaceutical Product Development PDF
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Author: Sarwar Beg
Publisher: Springer Nature
ISBN: 9813343516
Size: 11.86 MB
Format: PDF, Mobi
Category : Medical
Languages : en
Pages : 188
View: 519

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 dedicated case studies on various pharmaceutical experiments through illustrations, art-works, tables and figures. This book is a valuable guide for all academic and industrial researchers, pharmaceutical and biomedical scientists, undergraduate and postgraduate research scholars, pharmacists, biostatisticians, biotechnologists, formulations and process engineers, regulatory affairs and quality assurance personnel.


Nanoformulation Strategies For Cancer Treatment

Nanoformulation Strategies for Cancer Treatment PDF
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Author: Sarwar Beg
Publisher: Elsevier
ISBN: 0128210966
Size: 61.33 MB
Format: PDF, Docs
Category : Technology & Engineering
Languages : en
Pages : 402
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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 and therapy. Due to the high cost of traditional cancer treatment types, researchers have increasingly looked for new ways to augment the therapeutic performance of existing drug candidates. The use of nanotechnology-based approaches have gained significant momentum, thus leading to the launch of a series of new drug products. As nanopharmaceuticals improve the therapeutic performance of cancer therapy drugs, but also provide opportunities for site-specific drug targeting in tumors, this work is a welcomed resource on the topics discussed. Highlights the application of nanoformulations, including liposomes, nanoparticles and nanobiomaterials for targeted drug delivery to cancer cells Explores recent advances made using novel nanoformulations containing herbal drugs and biotechnology based therapeutic strategies for cancer treatment Assesses the regulatory hurdles that are necessary for the successful clinical translation of nanomedicines from the laboratory into the market


Comprehensive Quality By Design For Pharmaceutical Product Development And Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture PDF
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Author: Gintaras V. Reklaitis
Publisher: John Wiley & Sons
ISBN: 0470942371
Size: 76.74 MB
Format: PDF, Kindle
Category : Science
Languages : en
Pages : 416
View: 4117

This book is a structured approach to designing a product and its associated manufacturing process. It shows pharmaceutical engineers and scientists involved in product and process development how to utilize QbD practices and applications effectively while complying with government regulations. Material includes discussion of how to utilize design space, models, process control methodology, and cumulative process knowledge to seek improvements in manufacturing, while maintaining and enhancing product performance. Edited by three renowned researchers in the field, this invaluable resource is an essential tool for all pharmaceutical professionals.


Optimization Of Pharmaceutical R D Programs And Portfolios

Optimization of Pharmaceutical R D Programs and Portfolios PDF
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Author: Zoran Antonijevic
Publisher: Springer
ISBN: 3319090755
Size: 52.46 MB
Format: PDF, Kindle
Category : Business & Economics
Languages : en
Pages : 202
View: 307

Very little has been published on optimization of pharmaceutical portfolios. Moreover, most of published literature is coming from the commercial side, where probability of technical success (PoS) is treated as fixed, and not as a consequence of development strategy or design. In this book there is a strong focus on impact of study design on PoS and ultimately on the value of portfolio. Design options that are discussed in different chapters are dose-selection strategies, adaptive design and enrichment. Some development strategies that are discussed are indication sequencing, optimal number of programs and optimal decision criteria. This book includes chapters written by authors with very broad backgrounds including financial, clinical, statistical, decision sciences, commercial and regulatory. Many authors have long held executive positions and have been involved with decision making at a product or at a portfolio level. As such, it is expected that this book will attract a very broad audience, including decision makers in pharmaceutical R&D, commercial and financial departments. The intended audience also includes portfolio planners and managers, statisticians, decision scientists and clinicians. Early chapters describe approaches to portfolio optimization from big Pharma and Venture Capital standpoints. They have stronger focus on finances and processes. Later chapters present selected statistical and decision analysis methods for optimizing drug development programs and portfolios. Some methodological chapters are technical; however, with a few exceptions they require a relatively basic knowledge of statistics by a reader.


Handbook Of Analytical Quality By Design

Handbook of Analytical Quality by Design PDF
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Author: Sarwar Beg
Publisher: Academic Press
ISBN: 0128203331
Size: 44.14 MB
Format: PDF, Mobi
Category : Business & Economics
Languages : en
Pages : 222
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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 method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. Concise language for easy understanding of the novel and holistic concept Covers key aspects of analytical development and validation Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance


Nanopharmaceutical Advanced Delivery Systems

Nanopharmaceutical Advanced Delivery Systems PDF
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Author: Vivek Dave
Publisher: John Wiley & Sons
ISBN: 1119711673
Size: 21.51 MB
Format: PDF, ePub
Category : Computers
Languages : en
Pages : 512
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The book provides a single volume covering detailed descriptions about various delivery systems, their principles and how these are put in use for the treatment of multiple diseases. It is divided into four sections where the first section deals with the introduction and importance of novel drug delivery system. The second section deals with the most advanced drug delivery systems like microbubbles, dendrimers, lipid-based nanoparticles, nanofibers, microemulsions etc., describing the major principles and techniques of the preparations of the drug delivery systems. The third section elaborates on the treatments of diverse diseases like cancer, topical diseases, tuberculosis etc. The fourth and final section provides a brief informative description about the regulatory aspects of novel drug delivery system that is followed in various countries.


Nanoemulsions In Food Technology

Nanoemulsions in Food Technology PDF
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Author: Javed Ahmad
Publisher: CRC Press
ISBN: 1000454479
Size: 70.24 MB
Format: PDF, ePub, Docs
Category : Technology & Engineering
Languages : en
Pages : 326
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As of late, greater efforts are being made in the use of nanoemulsion techniques to encapsulate, protect, and deliver functional compounds for food applications, given their advantages over conventional emulsification techniques. In addition, delivery systems of nano-scale dimensions use low-energy emulsification methods and exclude the need of any solvent, heat, or sophisticated instruments in their production. Divided into three sections, Nanoemulsions in Food Technology: Development, Characterization, and Applications will provide in-depth information and comprehensive discussion over technologies, physical and nanostructural characterization, as well as applicability of the nanoemulsion technique in food sciences. It describes the techniques involved in nanoemulsion characterization, mainly dealing with interfacial and nanostructural characterization of nanoemulsions, different physical characterization techniques, as well as various imaging and separation techniques involved in its characterization. Key Features Provides a detailed discussion about the technology of nanoemulsion Explains how nanoemulsion technique is helpful in using essential oils of different biological sources Presents methods of preparation and recent advancements in manufacturing along with stability perspectives of this technique. Discusses recent advancements in manufacturing and reviews the stability perspectives of nanoemulsion techniques This book contains in-depth information on a technology overview, physical and nanostructural characterization, as well as applicability of the nanoemulsion technique in food sciences. It is a concise body of information that is beneficial to researchers, industries, and students alike. The contributing authors are drawn from a rich blend of experts in various areas of scientific field exploring nanoemulsion techniques for wider applications. Also available in the Food Analysis and Properties Series: Sequencing Technologies in Microbial Food Safety and Quality, edited by Devarajan Thangardurai, Leo M.L. Nollet, Saher Islam, and Jeyabalan Sangeetha (ISBN: 9780367351182) Chiral Organic Pollutants: Monitoring and Characterization in Food and the Environment, edited by Edmond Sanganyado, Basil K. Munjanja, and Leo M.L. Nollet (ISBN: 9780367429232) Analysis of Nanoplastics and Microplastics in Food, edited by Leo. M.L. Nollet and Khwaja Salahuddin Siddiqi (ISBN: 9781138600188)


Pharmaceutical Product Development

Pharmaceutical Product Development PDF
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Author: Vandana B. Patravale
Publisher: CRC Press
ISBN: 1498730787
Size: 28.94 MB
Format: PDF, Docs
Category : Medical
Languages : en
Pages : 433
View: 5593

Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.