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Generic Drug Product Development
  • Language: en
  • Pages: 292

Generic Drug Product Development

  • Type: Book
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  • Published: 2016-04-19
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  • Publisher: CRC Press

Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty dru

New Drug Approval Process
  • Language: en
  • Pages: 550

New Drug Approval Process

  • Type: Book
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  • Published: 2016-04-19
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  • Publisher: CRC Press

The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.Updated chapters include:advances in international regulatory requirements, including ICH guidelines and harmonizationa step-by-step

Polymorphism in Pharmaceutical Solids
  • Language: en
  • Pages: 654

Polymorphism in Pharmaceutical Solids

  • Type: Book
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  • Published: 2018-11-12
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  • Publisher: CRC Press

Using clear and practical examples, Polymorphism of Pharmaceutical Solids, Second Edition presents a comprehensive examination of polymorphic behavior in pharmaceutical development that is ideal for pharmaceutical development scientists and graduate students in pharmaceutical science. This edition focuses on pharmaceutical aspects of polymorphism a

Drug Delivery Nanoparticles Formulation and Characterization
  • Language: en
  • Pages: 418

Drug Delivery Nanoparticles Formulation and Characterization

  • Type: Book
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  • Published: 2016-04-19
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  • Publisher: CRC Press

Exploring fundamental concepts, Drug Delivery Nanoparticles Formulation and Characterization presents key aspects of nanoparticulate system development for various therapeutic applications and provides advanced methods used to file for regulatory approval.This comprehensive guide features:Process Analytical Techniques (PAT) used in manufacturing Na

Characterization of Pharmaceutical Nano- and Microsystems
  • Language: en
  • Pages: 410

Characterization of Pharmaceutical Nano- and Microsystems

Learn about the analytical tools used to characterize particulate drug delivery systems with this comprehensive overview Edited by a leading expert in the field, Characterization of Pharmaceutical Nano- and Microsystems provides a complete description of the analytical techniques used to characterize particulate drug systems on the micro- and nanoscale. The book offers readers a full understanding of the basic physicochemical characteristics, material properties and differences between micro- and nanosystems. It explains how and why greater experience and more reliable measurement techniques are required as particle size shrinks, and the measured phenomena grow weaker. Characterization of Ph...

Exploring Computational Pharmaceutics
  • Language: en
  • Pages: 629

Exploring Computational Pharmaceutics

Provides an extensive and up-to-date overview of the theory and application of computational pharmaceutics in the drug development process Exploring Computational Pharmaceutics - AI and Modeling in Pharma 4.0 introduces a variety of current and emerging computational techniques for pharmaceutical research. Bringing together experts from academia, industry, and regulatory agencies, this edited volume also explores the current state, key challenges, and future outlook of computational pharmaceutics while encouraging development across all sectors of the field. Throughout the text, the authors discuss a wide range of essential topics, from molecular modeling and process simulation to intelligen...

Biopharmaceutics
  • Language: en
  • Pages: 324

Biopharmaceutics

Explore the latest research in biopharmaceutics from leading contributors in the field In Biopharmaceutics - From Fundamentals to Industrial Practice, distinguished Scientists from the UK's Academy of Pharmaceutical Sciences Biopharmaceutica Focus Group deliver a comprehensive examination of the tools used within the field of biopharmaceutics and their applications to drug development. This edited volume is an indispensable tool for anyone seeking to better understand the field of biopharmaceutics as it rapidly develops and evolves. Beginning with an expansive introduction to the basics of biopharmaceutics and the context that underpins the field, the included resources go on to discuss how ...

International Pharmaceutical Product Registration
  • Language: en
  • Pages: 804

International Pharmaceutical Product Registration

  • Type: Book
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  • Published: 2016-04-19
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  • Publisher: CRC Press

Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.This cutting-edge resou

3D Printing of Pharmaceutical and Drug Delivery Devices
  • Language: en
  • Pages: 276

3D Printing of Pharmaceutical and Drug Delivery Devices

3D Printing of Pharmaceutical and Drug Delivery Devices 3D Printing of Pharmaceutical and Drug Delivery Devices Discover the latest, fast-developing technology to help move towards more cost-effective, small-batch, decentralized manufacturing of personalized systems 3D printing has revolutionized manufacturing. Its precision and flexibility have enabled the large-scale production of materials and devices too complex for conventional industrial manufacturing. This has been particularly revolutionary in the field of pharmaceutical production, where 3D printing is being integrated into the manufacture of both drugs and drug delivery devices. It has never been more important for industry profess...

Official Gazette of the United States Patent and Trademark Office
  • Language: en
  • Pages: 816

Official Gazette of the United States Patent and Trademark Office

  • Type: Book
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  • Published: 2002
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  • Publisher: Unknown

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