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Protein Formulation and Delivery
  • Language: en
  • Pages: 372

Protein Formulation and Delivery

  • Type: Book
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  • Published: 2007-10-26
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  • Publisher: CRC Press

This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product development process, providing a comprehensive review of mechanisms and causes of protein instability in formulation development, coverage of accelerated stability testing methods and relevant analytica

Biodrug Delivery Systems
  • Language: en
  • Pages: 490

Biodrug Delivery Systems

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

Biodrug Delivery Systems: Fundamentals, Applications and Clinical Development presents the work of an international group of leading experts in drug development and biopharmaceutical science who discuss the latest advances in biodrug delivery systems and associated techniques. The book discusses components of successful formulation, delivery, and p

Handbook of Pharmaceutical Granulation Technology
  • Language: en
  • Pages: 678

Handbook of Pharmaceutical Granulation Technology

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

The Third Edition presents all pharmaceutical industry personnel and those in academia with critical updates on the recent advances in granulation technology and changes in FDA regulatory guidelines. Addressing precisely how these recent innovations and revisions affect unit operation of particle generation and granulation, this text assists the re

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

New Drug Approval Process
  • Language: en
  • Pages: 472

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

Drug-Drug Interactions
  • Language: en
  • Pages: 769

Drug-Drug Interactions

  • Type: Book
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  • Published: 2019-01-03
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  • Publisher: CRC Press

Authored by renowned leaders in the field, this comprehensive volume covers all aspects of drug-drug interactions, including preclinical, clinical, toxicological, and regulatory perspectives.Thoroughly updated, this second edition reflects the significant advances and includes extensive new material on:key interplay between transporters and enzymes

Pharmaceutical Inhalation Aerosol Technology, Third Edition
  • Language: en
  • Pages: 731

Pharmaceutical Inhalation Aerosol Technology, Third Edition

  • Type: Book
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  • Published: 2019-03-26
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  • Publisher: CRC Press

This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to treat symptoms or the underlying causes of disease. It focuses on the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery. The expanded scope considers previously unaddressed aspects of pharmaceutical inhalation aerosol technology and the patient interface by including aerosol delivery, lung deposition and cleara...

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

Diffusional Release from a Porous Polymeric Matrix
  • Language: en
  • Pages: 172

Diffusional Release from a Porous Polymeric Matrix

  • Type: Book
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  • Published: 1988
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  • Publisher: Unknown

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Preclinical Drug Development
  • Language: en
  • Pages: 374

Preclinical Drug Development

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

Preclinical Drug Development, Second Edition discusses the broad and complicated realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology to industry trends and regulatory expectations to requirements that support clinical trials. Highlights of the Second Edition include: PharmacokineticsModeling and simula