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Pharmaceutical Preformulation and Formulation
  • Language: en
  • Pages: 562

Pharmaceutical Preformulation and Formulation

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

Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the ne

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

Proteins and Peptides
  • Language: en
  • Pages: 266

Proteins and Peptides

  • Type: Book
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  • Published: 2009-10-19
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  • Publisher: CRC Press

Addressing the increased use of protein and peptide candidates as treatments for previously untreatable diseases, this comprehensive and progressive source provides the reader with a roadmap to an increased understanding of issues critical for successfully developing a protein or peptide therapeutic candidate. Proteins and Peptides is

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

Active Pharmaceutical Ingredients
  • Language: en
  • Pages: 452

Active Pharmaceutical Ingredients

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

To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. This book is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally. This secoond edition brings readers up-to-date with the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries.

Generic Drug Product Development
  • Language: en
  • Pages: 334

Generic Drug Product Development

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

Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutica

Pharmaceutical Statistics
  • Language: en
  • Pages: 666

Pharmaceutical Statistics

  • Type: Book
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  • Published: 2009-12-23
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  • Publisher: CRC Press

Through the use of practical examples and solutions, Pharmaceutical Statistics: Practical and Clinical Applications, Fifth Edition provides the most complete and comprehensive guide to the various statistical applications and research issues in the pharmaceutical industry, particularly in clinical trials and bioequivalence studies.

Handbook of Drug Screening
  • Language: en
  • Pages: 506

Handbook of Drug Screening

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

Building upon the foundation of basics discussed in the previous edition, the Second Edition provides a more in-depth look at the latest methods and technologies of advanced drug screening, an essential function of drug discovery. With extensively updated content and 21 new chapters, this text examines:quality and efficiency of drug target validati

Pharmaceutical Process Engineering
  • Language: en
  • Pages: 230

Pharmaceutical Process Engineering

  • Type: Book
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  • Published: 2016-03-09
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  • Publisher: CRC Press

With step-by-step methods of drug production and knowledge of major unit operations and key concepts of pharmaceutical engineering, this guide will help to improve communication among the varied professionals working in the pharmaceutical industry. Key features: REVISION OF A BESTSELLER - Updates include recent advances in the field to keep pharmac

Modern Pharmaceutics, Two Volume Set
  • Language: en
  • Pages: 1220

Modern Pharmaceutics, Two Volume Set

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

This new edition brings you up-to-date on the role of pharmaceutics and its future paradigms in the design of medicines. Contributions from over 30 international thought leaders cover the core disciplines of pharmaceutics and the impact of biotechnology, gene therapy, and cell therapy on current findings. Modern Pharmaceutics helps you stay current