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Now Available in Paperback 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, Pharmaceutical Drug Product Development and Process Optimization: Effective Use of Quality by Design, 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. Providing an abundance of knowledge, this volume will be valuable for those who are engaged in pharmaceutical product development, including new drugs and generic drug products. Key features
CONTENTS: About the Authors / Editors: Editors: Sarwar Beg, PhD Assistant Professor, Pharmaceutics &Biopharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard University, New Delhi, India Sarwar Beg, PhD, is currently serving as Assistant Professor of Pharmaceutics & Biopharmaceutics at Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard University, New Delhi, India (Rank #1 in pharmacy as per the government of India). Prior to that, Dr. Beg has worked with Jubilant Generics Limited, Noida, India, as Research Scientist, where he was solely responsible for implementation of Quality by Design (QbD) in formulation development and analytical development of generic products. He has nearly a decade of experience in systematic development and characterization of novel and nanostructured drug delivery systems using QbD paradigms including Design of Experiments (DoE), Quality Risk Management (QRM), Multivariate Chemometric Approaches, and Advanced Biopharmaceutics and Pharmacokinetic. To date, Dr. Beg has authored over 150 publications including research and review papers in high-impact peer-reviewed journals, eight journal special issues, 12 books, 45 book chapters, and three Indian patent applications. He is a Regional Editor (Asia) of the journal Current Nanomedicine and is an editorial board member of several other journals. Dr. Beg has also participated and presented his research work and delivered lectures at several conferences held at India, China, Bangladesh, Canada and USA, receiving several best paper awards. His other awards include an Innovative Pharma Researcher Award 2016 by SIPRA Lab (Hyderabad), the Eudragit® Award 2014 in South-Asia by M/s Evonik (Germany), Budding QbD Scientist Award 2014 and Budding ADME Scientist Award 2013 by M/s Select Biosciences (UK), and the Novartis Biocamp Award 2012 (Hyderabad). In 2017, Dr. Sarwar was recognized by the Honorable Union Health Minister of India and Managing Director of Sun Pharmaceutical Industries with prestigious Sun Pharma Science Foundation Award. Mahfoozur Rahman, PhD Assistant Professor, Department of Pharmaceutical Sciences, Faculty of Health Science, Sam Higginbottom University of Agriculture, Technology & Sciences (SHUATS), Allahabad, India Mahfoozur Rahman, PhD, is an Assistant Professor at the Department of Pharmaceutical Sciences, Faculty of Health Science, Sam Higginbottom University of Agriculture, Technology & Sciences (SHUATS), Allahabad, India. To date he has published over 90 publications in peer-reviewed journals (such as Seminar in Cancer Biology, Drug Discovery Today, Nanomedicine, Expert Opinion on Drug Delivery), as well as 17 book chapters, four international books, and three articles in international magazines. Dr. Rahman has received several travel grants for various international congresses, such as IAPRD, MDS, Nano Today Conference, etc. He is also serving as the Guest Editor of several journals, such as Seminar Cancer Biology, Recent Patents on Anti-Infective Drug Discovery, and Current Nanomedicine, and is an editorial member for many prestigious journals. His major areas of research interest include development and characterization of nanosized drug delivery systems for inflammatory disorders including psoriasis, arthritis, neurodegenerative disorders, cancer, etc. In addition, he is also working on amalgamation of herbal medicinal plants with modern therapeutics in order to deliver a scientifically acceptable therapy for various diseases management. Syed Sarim Imam, PhD Associate Professor, College of Pharmacy, King Saud University, Saudi Arabia Syed Sarim Imam, PhD, is an Associate Professor at the College of Pharmacy, King Saud University, Saudi Arabia. He has more than 10 years of teaching and research experience. Dr. Imam has a list of more than 60 research/review manuscripts published in journals of international repute. He has also participated and presented his research work at several conferences held in India and abroad. He has contributed about 20 book chapters in books published by Elsevier, CRC, and Springer. Dr. Imam is reviewer to a large number of international and national journals of repute and is a member/fife member of many Indian scientific organizations. His research interests include drug delivery, brain targeting, formulation optimization, and lipid-based delivery systems. Dr. Imam earned his PhD from the faculty of Pharmacy, Jamia Hamdard, New Delhi, India. He received a research fellowship from the Indian Council of Medical Research, New Delhi, during his doctorate tenure. Nabil K. Alruwaili, PhD Pharmaceutics Department, School of Pharmacy, Jouf University, Sakaka, Saudi Arabia Nabil K. Alruwaili, PhD, is an Assistant Professor in the Pharmaceutics Department, School of Pharmacy, Jouf University, Sakaka, Saudi Arabia. He is the chairman of the Pharmaceutics Department. He obtained both his BSc (Pharmaceutical Sciences, 2008) and MSc (Quality Control of Pharmaceutics, 2011) from the College of Pharmacy at King Saud University (KSU), Riyadh, Saudi Arabia. He was awarded his PhD (Pharmaceutics, 2017) from Massachusetts College of Pharmacy and Health Sciences University, Boston, Massachusetts, USA. Previously, Dr. Alruwaili worked at the Saudi Food & Drug Authority in product evaluation and standards-setting administration Riyadh, Saudi Arabia, for three years. He has significant experience in assessment and registration dossiers submitted by companies for a variety of pharmaceutical products. There are many aspects to be assessed in such files, including Drug Master File (DMF), which involves drug design and manufacturing. Dr. Alruwaili is effective in building successful projects through open channels of communication and synergistic relationships across research disciplines in order to motivate others on all levels in the achievement of individual and organizational goals. He has published several articles and has presented papers at international and national scientific conferences. Majed Al Robaian, PhD Faculty of Pharmacy, Taif University, Saudi Arabia Majed AlRobaian, PhD, is the Dean of the Faculty of Pharmacy at Taif University, Saudi Arabia. He obtained his BSc from King Saud University in Riyadh Saudi Arabia and his MSc in Pharmaceutical Sciences from Strathclyde University in the United Kingdom in 2010 and his PhD from the same university in 2014. His research interests focus on drug delivery and in particular the delivery of therapeutic genes for the treatment of cancer. Before obtaining his PhD, he worked as Director of Pharmacy in King Abdulaziz Hospital, Saudi Arabia. Currently, he has been appointed as the Science Faculty Ambassador for Strathclyde University, UK. He is also a member of a number of committees in the Saudi Commission for Health Specialties. Sunil K. Panda, PhD Director of Research & Development, Menovo Pharmaceuticals, People’s Republic of China Sunil Kumar Panda, PhD, serves as Director of Research and Development at Menovo Pharmaceuticals (Shanghai stock exchange listed company) in the People’s Republic of China. He has rich research work experience with top Indian pharmaceutical companies, such as Zydus Cadila, Dr. Reddy’s Laboratories, Jubilant, and Unichem. He is an academic consultant to the Government College of Engineering and Technology, Bhubaneswar, India. With 14 years of research experience in India and abroad, he has received many international grants for pursuing his research. He is listed as a foreign research expert in the People |
Follow us for the latest from Apple Academic Press: AAP WELCOMES PROF. MOHAMMED KUDDUS, PhD, AS AAP’S NEW ACQUISITIONS EDITOR for books on biotechnology, enzymology, microbiology, bioinformatics, bioremediation, biomedical technology, value-added products etc. Dr. Kuddus is Head of the Department of Biochemistry at the College of Medicine, University of Hail, Kingdom of Saudi Arabia. He is listed in Elsevier/Stanford University World’s Top 2% Scientists. He seeks book proposals from potential editors to consider for publication with Apple Academic Press. Contact: kuddus@appleacademicpress.com for more information.
AAP welcomes Dr. Maulin P. Shah as AAP’s new acquisitions editor for books on Applied Microbiology, Environmental Biotechnology and Waste Management. Dr. Shah, a Scientist in the Industrial Wastewater Research Lab at Enviro Technology Ltd., India. seeks book proposals to consider for these topics and related areas: applied microbiology, environmental biotechnology and waste management, including environmental pollution, wastewater treatment, bioenergy, biofuel, circular economy, leachate treatment activated sludge process, environmental microbiology, agricultural microbiology, advance oxidation process, bio-electrochemical systems, bacterial genomics for wastewater treatment, and heavy metal remediation. maulinshah1979@gmail.com for more information. AAP is pleased to announce Shrikaant Kulkarni, PhD, as our new Senior Commissioning Editor for books in the areas of Polymer Sciences, Chemical Sciences, Nuclear Sciences, and Material Sciences. Dr. Kulkarni is Adjunct Professor, Faculty of Business, Victorian Institute of Technology, Melbourne, Australia; and Adjunct Professor, Centre of Research Outcome and Impact, Chitkara University, Punjab, India. You can reach him at Email: srkulkarni21@gmail.com for more information. New Book Series: AAP Series on Waste Biomass Valorization will explore the transformation of biomass resources into valuable products, addressing the growing need for sustainable alternatives to fossil fuels and non-renewable resources. For more information and to propose a book, please visit: Click here Congratulations to Hafiz Ansar Rasul Suleria, PhD, for receiving the Dean’s Award for Excellence in Research from the University of Melbourne, Australia, in recognition for his exceptional performance and strong commitment to advanced research in food science. Dr. Suleria is editor of AAP’s book series Innovations in Plant Science for Better Health: From Soil to Fork. For more information, visit: Click here Congratulations to Dr. Christian Mancas. His book Conceptual Data Modeling and Database Design: A Fully Algorithmic Approach was one of the 6 Best Data Modeling ebooks for Beginners by BookAuthority, a leading site for book recommendations. For more information, visit: Click here COMMENTS FROM AAP EDITORS AND AUTHORS AAP book title: Advances in Audiology and Hearing Science (2-volume set) “I have collaborated with AAP during the process of bringing my two-volume editing work to a final publishing phase. AAP support has been truly important throughout the initial and final stages of the book. While the majority of the publishing work is done at the early stages, the final touches that include the last-minute corrections of the authors are extremely crucial to the quality the book tries to convey. The assistance of AAP during the last stages of corrections and communication with the authors was a very positive contributor to my state of mind during those stressful moments. I recommend the publishing experience with AAP to other editors of scientific material.” —Stavros Hatzopoulos, PhD, Hearing Science Laboratory, University Hospital of Ferrara, Ferrara, Italy AAP book title: Nanotechnologies: The Physics of Nanomaterials (2-volume set) “I was very pleased with the interaction and support of the team at Apple Academic Press. They provided me with regular and useful information and updates throughout the publishing procedure. I am also very happy with the final product, which is of good quality. The books are now available and are professionally distributed through the various channels. I would like again to thank the team at AAP for all their hard work and support.” —David Schmool, PhD, Director, Groupe d’Etude de la Matière Condensée GEMaC, National Centre for Scientific Research, Université de Versailles/Saint-Quentin, Université Paris-Saclay,Versailles, France AAP book title: Physiology of Molluscs (2-volume set) “I have enjoyed the full benefit of support, encouragement, and kindness from the members of AAP I have had the pleasure of being associated with. In the same vein, I hope AAP was satisfied with the book series I have edited in advancing the knowledge. It has been a great journey and was a great pleasure and satisfaction. Advancing scholarship through publications is one of the best routes publishers can take, and I would hold AAP as one of the best ones.” —Saber Saleuddin, PhD, University Professor Emeritus, Department of Biology, York University in Toronto, Ontario, Canada AAP book title: Green Chemistry and Sustainable Technology: Biological, Pharmaceutical, and Macromolecular Systems “It had been my pleasure to work with the production team of Apple Academic Press for almost a decade. The best presentation of our work was due to their hard work and with careful scrutiny. I am sure that every one of them takes extra pains to publish the book nicely, maintaining the quality and timeliness. It was a rewarding experience to work with AAP. I would like to publish more with AAP on my upcoming projects in future also.” —Prof. Suresh C. Ameta, Professor of Eminence (Distinguished Professor), Faculty of Science, PAHER University, UDAIPUR, India AAP book title: New Frontiers in Nanochemistry, 3-volume set, plus many others "Publishing a book, either as author or editor, is a journey from the initial vibration to the piece of knowledge towards the present future of humanity at large. Such a journey is about climbing and tunneling, about diving and driving through, about inspiration and tuning, about hard working in every instance; and it is also about time. Very few Global Publishers have the wisdom and patience and kindness and openness to authors, contributors, and readers while being truly crafting oriented as Apple Academic; yet all is about people and their education, vision and assumed mission; the Apple Academic Team heartily succeed that in achieving the world class scholarly acclaim by the quality involvement in all chain of plus value added with each publishing event. Hearty Compliments! Excelsior Apple Academic!" —Mihai V. Putz, PhD, Dr.-Habil., MBA, Professor, Faculty of Chemistry, Biology, Geography, Laboratory of Computational and Structural Physical Chemistry for Nanosciences and QSAR, West University of Timi?oara; PI-1, Laboratory of Renewable Energies - Photovoltaics, National Research and Development Institute for Electrochemistry and Condensed Matter (INCEM), Timi?oara, Romania AAP book title: The Chemical Century: Molecular Manipulation and Its Impact on the 20th Century “All my experiences with AAP have been very positive. I entrusted AAP with the publication of The Chemical Century: Molecular Manipulation and Its Impact on the 20th Century and found the quality of the book that they produced to be excellent. My two contacts at the company were very responsive and efficient throughout the publication process.” —Richard J. Sundberg, PhD, Professor of Chemistry, University of Virginia, Charlottesville, Virginia, USA AAP book titles: Medical Tourism and Wellness: Hospitality Bridging Healthcare (H2H)© and Medical Travel Brand Management: Success Strategies for Hospitality Bridging Healthcare (H2H) “I have enjoyed my scholarly creative work with Apple Academic Press. They have been timely, creative, and very helpful for my two books with them. I encourage you to consider publishing your work with AAP.” —Frederick DeMicco, PhD, RDN, Executive Director and Professor School of Hotel and Restaurant Management, Northern Arizona University, Flagstaff, Arizona AAP book title: The Chemical Evolution of Phosphorus: An Interdisciplinary Approach to Astrobiology “I’m very pleased with the books you have edited. It shows a very good and careful work by everyone involved along the whole production process, and so the final result is a beautiful piece: it has come out as a very nice and appealing book, easy to handle and read, .... and hopefully of interest for people from diverse related fields!” —Enrique Macia-Barber, PhD, Professor of Condensed Matter Physics, Universidad Complutense de Madrid, Spain |