How to Develop Robust Solid Oral Dosage Forms

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

"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

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

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

• Author : Bhavishya Mittal
• Publisher : Academic Press
• Release Date : 2019-08-24
• ISBN : 9780128173046

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

• Author : Valentina Emilia Balas,Vijender Kumar Solanki,Raghvendra Kumar
• Publisher : Academic Press
• Release Date : 2020-05-15
• ISBN : 9780128213278

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.

• Author : Igor Gorsky,Harold S. Baseman
• Publisher : Academic Press
• Release Date : 2019-11-27
• ISBN : 9780128094464

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

• Author : Wendy Charles
• Publisher : Springer Nature
• Release Date : 2022
• ISBN : 9789811929762

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

• Author : Shaik Feroz,Detlef W. Bahnemann
• Publisher : CRC Press
• Release Date : 2021-12-23
• ISBN : 9781000520620

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

• Author : Sarfaraz K. Niazi
• Publisher : CRC Press
• Release Date : 2007-08-22
• ISBN : 9780849383595

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

• Author : Ashok Katdare,Mahesh Chaubal
• Publisher : CRC Press
• Release Date : 2006-07-28
• ISBN : 9781420004137

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

• Author : Lawrence X. Yu,Bing V. Li
• Publisher : Springer
• Release Date : 2014-09-05
• ISBN : 9781493912520

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

• Author : Anonim
• Publisher : Academic Press
• Release Date : 2018-07-28
• ISBN : 9780128144244

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

• Author : Sarfaraz K. Niazi
• Publisher : CRC Press
• Release Date : 2004-04-27
• ISBN : 9781420048452

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

• Author : Rajesh Krishna,Lawrence Yu
• Publisher : Springer Science & Business Media
• Release Date : 2007-09-20
• ISBN : 9780387723792

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.

• Author : Ajit S. Narang,Sherif I.F. Badawy
• Publisher : Academic Press
• Release Date : 2018-08-31
• ISBN : 9780323481038

Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling,

• Author : Jennifer J. Dressman,Johannes Kramer
• Publisher : CRC Press
• Release Date : 2005-07-08
• ISBN : 0824754670

An expertly written source on the devices, systems, and technologies used in the dissolution testing of oral pharmaceutical dosage forms, this reference provides reader-friendly chapters on currently utilized equipment, equipment qualification, consideration of the gastrointestinal physiology in test design, the analysis and interpretation of data and procedure automation -laying the foundation for the creation of appropriate and useful dissolution tests according to the anticipated location and duration of drug release from the dosage form within the gastrointestinal tract.