How to Develop Robust Solid Oral Dosage Forms Book

How to Develop Robust Solid Oral Dosage Forms


  • Author : Bhavishya Mittal
  • Publisher : Academic Press
  • Release Date : 2016-10-01
  • Genre: Uncategoriezed
  • Pages : 192
  • ISBN 10 : 0128047313

DOWNLOAD BOOK
How to Develop Robust Solid Oral Dosage Forms Excerpt :

"How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval "uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more Part of the "Expertise in Pharmaceutical Process Technology" series edited by Michael LevinDiscusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues

How to Develop Robust Solid Oral Dosage Forms Book

How to Develop Robust Solid Oral Dosage Forms


  • Author : Bhavishya Mittal
  • Publisher : Academic Press
  • Release Date : 2016-10-05
  • Genre: Medical
  • Pages : 190
  • ISBN 10 : 9780128047323

DOWNLOAD BOOK
How to Develop Robust Solid Oral Dosage Forms Excerpt :

How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues

How to Integrate Quality by Efficient Design  QbED  in Product Development Book

How to Integrate Quality by Efficient Design QbED in Product Development


  • Author : Bhavishya Mittal
  • Publisher : Academic Press
  • Release Date : 2019-08-24
  • Genre: Business & Economics
  • Pages : 274
  • ISBN 10 : 9780128173046

DOWNLOAD BOOK
How to Integrate Quality by Efficient Design QbED in Product Development Excerpt :

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 companies have seen a notable change in the traditional operating model and footprint over the past couple of decades. Outsourcing, in particular, has emerged as a successful business model for many pharmaceutical companies looking for ways to strategically increase their R&D capabilities and to augment their in-house resources. How to Integrate Quality by Efficient Design (QbED) in Product Development bridges the gap between theory and practice when it comes to strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as patient-centric product designs, platform-based manufacturing technologies, business acuity, and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, quality by design (QbD), business analytics, and manufacturing excellence specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, How to Integrate Quality by Efficient Design (QbED) in Product Development will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management. Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Integrates pharmaceutical business models, economics, and outsourcing-related challenges into pharmaceutical product developmen

An Industrial IoT Approach for Pharmaceutical Industry Growth Book

An Industrial IoT Approach for Pharmaceutical Industry Growth


  • Author : Valentina Emilia Balas
  • Publisher : Academic Press
  • Release Date : 2020-05-15
  • Genre: Business & Economics
  • Pages : 382
  • ISBN 10 : 9780128213278

DOWNLOAD BOOK
An Industrial IoT Approach for Pharmaceutical Industry Growth Excerpt :

An Industrial IoT Approach for Pharmaceutical Industry Growth, Volume Two uses an innovative approach to explore how the Internet of Things (IoT) and big data can improve approaches and make discoveries. Rapid growth of the IoT has encouraged many companies in the manufacturing sector to make use of this technology to unlock its potential. Using clear language and real-world case studies, this book discusses systems level from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing. The wide variety in topics presented offers multiple perspectives on how to integrate the Internet of Things into pharmaceutical manufacturing. This book represents a useful resource for researchers in pharmaceutical sciences, information and communication technologies, and those who specialize in healthcare and pharmacovigilance. Emphasizes efficiency in pharmaceutical manufacturing through an IoT/Big Data approach Explores cutting-edge technologies through sensor enabled environments in the pharmaceutical industry Discusses system levels from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing

Principles of Parenteral Solution Validation Book

Principles of Parenteral Solution Validation


  • Author : Igor Gorsky
  • Publisher : Academic Press
  • Release Date : 2019-11-27
  • Genre: Medical
  • Pages : 298
  • ISBN 10 : 9780128094464

DOWNLOAD BOOK
Principles of Parenteral Solution Validation Excerpt :

Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. Discusses international and domestic regulatory considerations in every section Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more

Blockchain in Life Sciences Book

Blockchain in Life Sciences


  • Author : Wendy Charles
  • Publisher : Springer Nature
  • Release Date : 2022
  • Genre: Blockchains (Databases)
  • Pages : 349
  • ISBN 10 : 9789811929762

DOWNLOAD BOOK
Blockchain in Life Sciences Excerpt :

This book highlights the latest advances on the implementation and adaptation of blockchain technologies in real-world scientific, biomedical, and data applications. It presents rapid advancements in life sciences research and development by applying the unique capabilities inherent in distributed ledger technologies. The book unveils the current uses of blockchain in drug discovery, drug and device tracking, real-world data collection, and increased patient engagement used to unlock opportunities to advance life sciences research. This paradigm shift is explored from the perspectives of pharmaceutical professionals, biotechnology start-ups, regulatory agencies, ethical review boards, and blockchain developers. This book enlightens readers about the opportunities to empower and enable data in life sciences.

Removal of Pollutants from Saline Water Book

Removal of Pollutants from Saline Water


  • Author : Shaik Feroz
  • Publisher : CRC Press
  • Release Date : 2021-12-23
  • Genre: Technology & Engineering
  • Pages : 438
  • ISBN 10 : 9781000520620

DOWNLOAD BOOK
Removal of Pollutants from Saline Water Excerpt :

Removal of Pollutants from Saline Water: Treatment Technologies provides a comprehensive understanding of technologies that are currently adopted in the treatment of pollutants present in saline water systems. It provides information on the treatment technologies for saline water systems, including seawater, brackish water, oil-produced water, and other industrial saline wastewaters. FEATURES Presents information exclusively for saline water pollutant removal Introduces current treatment technologies and addresses why and how the techniques differ between fresh and salt water Offers an inclusive overview of physicochemical, biological, membrane, and advanced oxidation treatment technologies Features various perspectives and case studies from relevant global experts Provides a comprehensive one-stop source for the treatment of pollutants in all saline water systems Aimed at students, academicians, researchers, and practicing engineers in the fields of chemical, civil, marine, and environmental engineering who wish to be acquainted with the most recent developments in the treatment of pollutants present in saline water systems. Prof. Dr. Shaik Feroz works at Prince Mohammad Bin Fahd University, Kingdom of Saudi Arabia. He has 30 years of experience in teaching, research, and industry. He has more than 190 publications to his credit in journals and conferences of international repute. He was awarded "Best Researcher" by Caledonian College of Engineering for the year 2014. Prof. Dr. Detlef W. Bahnemann is Head of the Research Unit, Photocatalysis and Nanotechnology at Leibniz University Hannover (Germany), Director of the Research Institute "Nanocomposite Materials for Photonic Applications" at Saint Petersburg State University (Russian Federation), and Distinguished Professor at Shaanxi University of Science and Technology in Xi’an (People's Republic of China). His research topics include photocatalysis, photoelectrochemistry, solar chemistry, and photochemistry focu

Handbook of Bioequivalence Testing Book
Score: 5
From 1 Ratings

Handbook of Bioequivalence Testing


  • Author : Sarfaraz K. Niazi
  • Publisher : CRC Press
  • Release Date : 2007-08-22
  • Genre: Medical
  • Pages : 602
  • ISBN 10 : 9780849383595

DOWNLOAD BOOK
Handbook of Bioequivalence Testing Excerpt :

As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made

Excipient Development for Pharmaceutical  Biotechnology  and Drug Delivery Systems Book
Score: 5
From 1 Ratings

Excipient Development for Pharmaceutical Biotechnology and Drug Delivery Systems


  • Author : Ashok Katdare
  • Publisher : CRC Press
  • Release Date : 2006-07-28
  • Genre: Medical
  • Pages : 452
  • ISBN 10 : 9781420004137

DOWNLOAD BOOK
Excipient Development for Pharmaceutical Biotechnology and Drug Delivery Systems Excerpt :

To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new excipients to be developed and approved continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge new avenue

Handbook of Pharmaceutical Manufacturing Formulations Book

Handbook of Pharmaceutical Manufacturing Formulations


  • Author : Sarfaraz K. Niazi
  • Publisher : CRC Press
  • Release Date : 2004-04-27
  • Genre: Medical
  • Pages : 256
  • ISBN 10 : 9781420048452

DOWNLOAD BOOK
Handbook of Pharmaceutical Manufacturing Formulations Excerpt :

The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emul

FDA Bioequivalence Standards Book

FDA Bioequivalence Standards


  • Author : Lawrence X. Yu
  • Publisher : Springer
  • Release Date : 2014-09-05
  • Genre: Medical
  • Pages : 465
  • ISBN 10 : 9781493912520

DOWNLOAD BOOK
FDA Bioequivalence Standards Excerpt :

This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.

Dosage Form Design Considerations Book

Dosage Form Design Considerations


  • Author : Anonim
  • Publisher : Academic Press
  • Release Date : 2018-07-28
  • Genre: Medical
  • Pages : 820
  • ISBN 10 : 9780128144244

DOWNLOAD BOOK
Dosage Form Design Considerations Excerpt :

Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Biopharmaceutics Applications in Drug Development Book

Biopharmaceutics Applications in Drug Development


  • Author : Rajesh Krishna
  • Publisher : Springer Science & Business Media
  • Release Date : 2007-09-20
  • Genre: Medical
  • Pages : 396
  • ISBN 10 : 9780387723792

DOWNLOAD BOOK
Biopharmaceutics Applications in Drug Development Excerpt :

The highly experienced authors here present readers with step-wise, detail-conscious information to develop quality pharmaceuticals. The book is made up of carefully crafted sections introducing key concepts and advances in the areas of dissolution, BA/BE, BCS, IVIC, and product quality. It provides a specific focus on the integration of regulatory considerations and includes case histories highlighting the biopharmaceutics strategies adopted in development of successful drugs.

Drug Metabolism  Pharmacokinetics and Bioanalysis Book

Drug Metabolism Pharmacokinetics and Bioanalysis


  • Author : Hye Suk Lee
  • Publisher : MDPI
  • Release Date : 2019-06-12
  • Genre: Medical
  • Pages : 230
  • ISBN 10 : 9783038979166

DOWNLOAD BOOK
Drug Metabolism Pharmacokinetics and Bioanalysis Excerpt :

Drug metabolism/pharmacokinetics and drug interaction studies have been extensively carried out in order to secure the druggability and safety of new chemical entities throughout the development of new drugs. Recently, drug metabolism and transport by phase II drug metabolizing enzymes and drug transporters, respectively, as well as phase I drug metabolizing enzymes, have been studied. A combination of biochemical advances in the function and regulation of drug metabolizing enzymes and automated analytical technologies are revolutionizing drug metabolism research. There are also potential drug–drug interactions with co-administered drugs due to inhibition and/or induction of drug metabolic enzymes and drug transporters. In addition, drug interaction studies have been actively performed to develop substrate cocktails that do not interfere with each other and a simultaneous analytical method of substrate drugs and their metabolites using a tandem mass spectrometer. This Special Issue has the aim of highlighting current progress in drug metabolism/pharmacokinetics, drug interactions, and bioanalysis.

Pharmaceutical Product Development Book

Pharmaceutical Product Development


  • Author : Vandana B. Patravale
  • Publisher : CRC Press
  • Release Date : 2016-05-25
  • Genre: Medical
  • Pages : 433
  • ISBN 10 : 9781498730785

DOWNLOAD BOOK
Pharmaceutical Product Development Excerpt :

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.