Pharmaceutical Drug Product Development And Process Optimization

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Pharmaceutical Drug Product Development And Process Optimization

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Author : Sarwar Beg
language : en
Publisher: CRC Press
Release Date : 2020-05-01

Pharmaceutical Drug Product Development And Process Optimization written by Sarwar Beg and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-05-01 with Business & Economics categories.

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

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Author : Sarwar Beg
language : en
Publisher: CRC Press
Release Date : 2020-05-01

Pharmaceutical Drug Product Development And Process Optimization written by Sarwar Beg and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-05-01 with Business & Economics categories.

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

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Author : Sarwar Beg
language : en
Publisher: Springer Nature
Release Date : 2021-01-22

Design Of Experiments For Pharmaceutical Product Development written by Sarwar Beg and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-01-22 with Medical categories.

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.

Pharmaceutical Drug Product Development And Process Optimization

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Author : Taylor & Francis Group
language : en
Publisher: Apple Academic Press
Release Date : 2021-12-13

Pharmaceutical Drug Product Development And Process Optimization written by Taylor & Francis Group and has been published by Apple Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-12-13 with categories.

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.

Pharmaceutical Quality By Design

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Author : Sarwar Beg
language : en
Publisher: Academic Press
Release Date : 2019-03-27

Pharmaceutical Quality By Design written by Sarwar Beg and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-27 with Medical categories.

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

Bioinformatics Tools For Pharmaceutical Drug Product Development

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Author : Vivek P. Chavda
language : en
Publisher: John Wiley & Sons
Release Date : 2023-02-09

Bioinformatics Tools For Pharmaceutical Drug Product Development written by Vivek P. Chavda and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-02-09 with Medical categories.

BIOINFORMATICS TOOLS FOR Pharmaceutical DRUG PRODUCT DLEVELOPMENT A timely book that details bioinformatics tools, artificial intelligence, machine learning, computational methods, protein interactions, peptide-based drug design, and omics technologies, for drug development in the pharmaceutical and medical sciences industries. The book contains 17 chapters categorized into 3 sections. The first section presents the latest information on bioinformatics tools, artificial intelligence, machine learning, computational methods, protein interactions, peptide-based drug design, and omics technologies. The following 2 sections include bioinformatics tools for the pharmaceutical sector and the healthcare sector. Bioinformatics brings a new era in research to accelerate drug target and vaccine design development, improving validation approaches as well as facilitating and identifying side effects and predicting drug resistance. As such, this will aid in more successful drug candidates from discovery to clinical trials to the market, and most importantly make it a more cost-effective process overall. Readers will find in this book: Applications of bioinformatics tools for pharmaceutical drug product development like process development, pre-clinical development, clinical development, commercialization of the product, etc.; The ever-expanding application of this novel technology and discusses some of the unique challenges associated with such an approach; The broad and deep background, as well as updates, on recent advances in both medicine and AI/ML that enable the application of these cutting-edge bioinformatics tools. Audience The book will be used by researchers and scientists in academia and industry including drug developers, computational biochemists, bioinformaticians, immunologists, pharmaceutical and medical sciences, as well as those in artificial intelligence and machine learning.

Advances In Pharmaceutical Product Development

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Author : Keerti Jain
language : en
Publisher: Springer Nature
Release Date : 2025-03-18

Advances In Pharmaceutical Product Development written by Keerti Jain and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-03-18 with Medical categories.

This book discusses the stages involved in pharmaceutical product development including the importance, requirement, and effect of each stage and process. It also covers prototype development for pharmaceutical formulations, scale-up studies, optimization, testing, packaging, and commercialization of different dosage forms for pharmaceutical products like tablets, suspensions, emulsions, coating, inhalational products, sterile products, and herbal formulations. The book also presents advancements in tablet production and tablet coating, including materials, material handling, granulation and granulation technologies, process automation, processing problems in tablet production and troubleshooting, advances in equipment for coating and coating materials. Further, the chapter explores the advances in the formulation and development of aerosols, nebulizers, inhalers, metered Dose Inhalers (MDI), and dry powder Inhalers (DPIs). Towards the end, the book examines the challenges, formulation development, testing, stability, and regulatory guidelines in the development of herbal formulations. This book provides a valuable source of information for the researcher, scientists, students, and people working in the area mainly focused on the challenges in pharmaceutical product development. ​

Sustainable Pharmaceutical Product Development And Optimization Processes

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Author : Bancha Yingngam
language : en
Publisher: Springer Nature
Release Date : 2025-01-30

Sustainable Pharmaceutical Product Development And Optimization Processes written by Bancha Yingngam and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-01-30 with Science categories.

This book offers unparalleled insight into the convergence of sustainability and pharmaceutical product development, with a specific focus on optimization processes. By addressing the urgent demand for more environmentally conscious and efficient strategies in the drug development industry, particularly in an era where the world faces the mounting challenges posed by climate change, the book provides a comprehensive guide for integrating sustainability principles throughout the pharmaceutical product lifecycle, directly contributing to the United Nations Sustainable Development Goals (SDGs), such as SDG 12 (Responsible Consumption and Production) and SDG 13 (Climate Action). The chapters cover key topics, including the application of green chemistry, eco-design principles, sustainable sourcing of raw materials, waste reduction strategies, and the use of renewable energy in pharmaceutical manufacturing processes. Throughout the book, case studies are integrated, offering practical insights and concurrently highlighting the economic and environmental advantages of sustainable practices, thereby addressing skepticism regarding the feasibility and profitability of such initiatives. The book also discusses regulatory considerations, ethical implications, and the challenges and opportunities associated with moving toward more sustainable practices in pharmaceutical development. Importantly, this book seeks to solve the problem of the knowledge gap and lack of practical resources for professionals in the pharmaceutical industry who aspire to implement sustainable and optimized processes. This work consolidates a network of professionals and scholars keenly focused on future sustainability challenges, developing enhancement methodologies, and sharing successful strategies for implementing eco-friendly practices in pharmaceutical sectors worldwide, ultimately contributing to the global effort to achieve the SDGs by 2030. With a focus on pharmaceutical professionals, researchers, academicians, and students, the book serves as a valuable reference for those involved in drug development and process optimization. Policymakers and regulatory bodies might also find it insightful, as it addresses current landscapes, challenges, and future directions in sustainable pharmaceutical product development.

Nanoformulation Strategies For Cancer Treatment

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Author : Sarwar Beg
language : en
Publisher: Elsevier
Release Date : 2020-11-20

Nanoformulation Strategies For Cancer Treatment written by Sarwar Beg and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-11-20 with Technology & Engineering categories.

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

Pharmaceutical Product Development

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Author : Mr. Rohit Manglik
language : en
Publisher: EduGorilla Publication
Release Date : 2024-04-06

Pharmaceutical Product Development written by Mr. Rohit Manglik and has been published by EduGorilla Publication this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-04-06 with Medical categories.

EduGorilla Publication is a trusted name in the education sector, committed to empowering learners with high-quality study materials and resources. Specializing in competitive exams and academic support, EduGorilla provides comprehensive and well-structured content tailored to meet the needs of students across various streams and levels.