Advanced Pharmaceutical Solids

Advanced Pharmaceutical Solids

Author: Jens T. Carstensen

Publisher: CRC Press

Published: 2000-10-24

Total Pages: 529

ISBN-13: 1482270544

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This extensive reference/text explores the principles, instrumentation, processes, and programs of pharmaceutical solid science as well as new aspects on one-component systems, micromeritics, polymorphism, solid-state stability, cohesion, powder flow, blending, single- unit sustained release, and tablet coating. Reveals unique approaches in phar


Advances in Pharmaceutical Biotechnology

Advances in Pharmaceutical Biotechnology

Author: Jayanta Kumar Patra

Publisher: Springer Nature

Published: 2020-03-30

Total Pages: 473

ISBN-13: 9811521956

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This book explains both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical uses. The foundations of pharmaceutical biotechnology lie mainly in the capability of plants, microorganism, and animals to produce low and high molecular weight compounds useful as therapeutics. Pharmaceutical biotechnology has flourished since the advent of recombinant DNA technology and metabolic engineering, supported by the well-developed bioprocess technology. A large number of monoclonal antibodies and therapeutic proteins have been approved, delivering meaningful contributions to patients’ lives, and the techniques of biotechnology are also a driving force in modern drug discovery. Due to this rapid growth in the importance of biopharmaceuticals and the techniques of biotechnologies to modern medicine and the life sciences, the field of pharmaceutical biotechnology has become an increasingly important component in the education of pharmacists and pharmaceutical scientists. This book will serve as a complete one-stop source on the subject for undergraduate and graduate pharmacists, pharmaceutical science students, and pharmaceutical scientists in industry and academia.


Pharmaceutical Quality by Design

Pharmaceutical Quality by Design

Author: Walkiria S. Schlindwein

Publisher: John Wiley & Sons

Published: 2018-01-05

Total Pages: 319

ISBN-13: 1118895215

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A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.


Advanced Aseptic Processing Technology

Advanced Aseptic Processing Technology

Author: James Agalloco

Publisher: CRC Press

Published: 2016-04-19

Total Pages: 495

ISBN-13: 1439825440

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The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies


Formulating Poorly Water Soluble Drugs

Formulating Poorly Water Soluble Drugs

Author: Robert O. Williams III

Publisher: Springer Science & Business Media

Published: 2011-12-04

Total Pages: 656

ISBN-13: 1461411440

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This volume is intended to provide the reader with a breadth of understanding regarding the many challenges faced with the formulation of poorly water-soluble drugs as well as in-depth knowledge in the critical areas of development with these compounds. Further, this book is designed to provide practical guidance for overcoming formulation challenges toward the end goal of improving drug therapies with poorly water-soluble drugs. Enhancing solubility via formulation intervention is a unique opportunity in which formulation scientists can enable drug therapies by creating viable medicines from seemingly undeliverable molecules. With the ever increasing number of poorly water-soluble compounds entering development, the role of the formulation scientist is growing in importance. Also, knowledge of the advanced analytical, formulation, and process technologies as well as specific regulatory considerations related to the formulation of these compounds is increasing in value. Ideally, this book will serve as a useful tool in the education of current and future generations of scientists, and in this context contribute toward providing patients with new and better medicines.


The Future of Pharmaceutical Product Development and Research

The Future of Pharmaceutical Product Development and Research

Author:

Publisher: Academic Press

Published: 2020-09-02

Total Pages: 974

ISBN-13: 0128144556

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The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries. Provides an overview of practical information for clinical trials Outlines how to ensure an environment that follows Good Manufacturing Practice (GMP) Examines recent developments and suggests future directions for drug production methods and techniques


Biopharmaceutics and Pharmacokinetics Considerations

Biopharmaceutics and Pharmacokinetics Considerations

Author:

Publisher: Academic Press

Published: 2021-07-07

Total Pages: 754

ISBN-13: 0128144262

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Biopharmaceutics and Pharmacokinetics Considerations examines the history of biopharmaceutics and pharmacokinetics. The book provides a biopharmaceutics and pharmacokinetics approach to addressing issues in formulation development and ethical considerations in handling animals. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biopharmaceutics and pharmacokinetics within drug discovery and drug development. Each chapter delves into a particular aspect of this fundamental field to cover the principles, methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to study the chemical and physical properties of drugs and the biological effects they produce. - Examines the most recent developments in biopharmaceutics and pharmacokinetics for pharmaceutical sciences - Covers the principles, methodologies and technologies of biopharmaceutics and pharmacokinetics - Focuses on the pharmaceutical sciences, but also encompasses aspects of toxicology, neuroscience, environmental sciences and nanotechnology


Strong Medicine

Strong Medicine

Author: Michael Kremer

Publisher: Princeton University Press

Published: 2016-05-31

Total Pages: 168

ISBN-13: 1400880149

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From Nobel Prize–winning economist Michael Kremer and fellow leading development economist Rachel Glennerster, an innovative solution for providing vaccines in poor countries Millions of people in the third world die from diseases that are rare in the first world—diseases like malaria, tuberculosis, and schistosomiasis. AIDS, which is now usually treated in rich countries, still ravages the world's poor. Vaccines offer the best hope for controlling these diseases and could dramatically improve health in poor countries. But developers have little incentive to undertake the costly and risky research needed to develop vaccines. This is partly because the potential consumers are poor, but also because governments drive down prices. In Strong Medicine, Michael Kremer and Rachel Glennerster offer an innovative yet simple solution to this worldwide problem: "Pull" programs to stimulate research. Here's how such programs would work. Funding agencies would commit to purchase viable vaccines if and when they were developed. This would create the incentives for vaccine developers to produce usable products for these neglected diseases. Private firms, rather than funding agencies, would pick which research strategies to pursue. After purchasing the vaccine, funders could distribute it at little or no cost to the afflicted countries. Strong Medicine details just how these legally binding commitments would work. Ultimately, if no vaccines were developed, such a commitment would cost nothing. But if vaccines were developed, the program would save millions of lives and would be among the world's most cost-effective health interventions.


Advances In Pharmaceutical Cell Therapy: Principles Of Cell-based Biopharmaceuticals

Advances In Pharmaceutical Cell Therapy: Principles Of Cell-based Biopharmaceuticals

Author: Christine Guenther

Publisher: World Scientific

Published: 2015-09-23

Total Pages: 565

ISBN-13: 981461680X

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This textbook is a comprehensive overview of the development of cell-based biopharmaceuticals. Beginning with the underlying biology of stem cell and cell-based products, it traces the long and complex journey from preclinical concept to initiation of a pivotal clinical trial and the potential business model behind it.The book also takes into consideration the different regulatory landscapes and their continuous evolution in Europe, North America and other parts of the world. The authors describe a path to manufacture a clinical grade therapeutic that passes all necessary quality measures as a robust and marketable product including an outlook on next generation products and innovative strategies.This reference book is a must-have guide for any professional already active in biopharmaceuticals and anyone interested in getting involved in a scientific, medical or business capacity.