How to Develop Robust Solid Oral Dosage Forms

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  • Publisher : Academic Press
  • Release : 01 October 2016
  • ISBN : 0128047313
  • Page : 192 pages
  • Rating : 4.5/5 from 103 voters

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"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

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How to Develop Robust Solid Oral Dosage Forms

How to Develop Robust Solid Oral Dosage Forms
  • Author : Bhavishya Mittal
  • Publisher : Academic Press
  • Release Date : 2016-10-01
  • ISBN : 0128047313
GET THIS BOOKHow to Develop Robust Solid Oral Dosage Forms

"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

How to Develop Robust Solid Oral Dosage Forms

How to Develop Robust Solid Oral Dosage Forms
  • Author : Bhavishya Mittal
  • Publisher : Academic Press
  • Release Date : 2016-10-05
  • ISBN : 9780128047323
GET THIS BOOKHow to Develop Robust Solid Oral Dosage Forms

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

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  • Publisher : Academic Press
  • Release Date : 2019-08-24
  • ISBN : 9780128173046
GET THIS BOOKHow to Integrate Quality by Efficient Design (QbED) in Product Development

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

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  • ISBN : 9780128213278
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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.

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GET THIS BOOKPrinciples of Parenteral Solution Validation

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

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  • ISBN : 9781000520620
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GET THIS BOOKHandbook of Bioequivalence Testing

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

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GET THIS BOOKExcipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems

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

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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

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