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Produktbild: Qiu, Y: Developing Solid Oral Dosage Forms
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Qiu, Y: Developing Solid Oral Dosage Forms Pharmaceutical Theory and Practice

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Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

01.12.2016

Herausgeber

Qiu Yihong + weitere

Verlag

Elsevier LTD, Oxford

Seitenzahl

1176

Maße (L/B/H)

28,5/22,5/6,2 cm

Gewicht

2580 g

Auflage

2. Auflage

Sprache

Englisch

ISBN

978-0-12-802447-8

Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

01.12.2016

Herausgeber

Verlag

Elsevier LTD, Oxford

Seitenzahl

1176

Maße (L/B/H)

28,5/22,5/6,2 cm

Gewicht

2580 g

Auflage

2. Auflage

Sprache

Englisch

ISBN

978-0-12-802447-8

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  • Produktbild: Qiu, Y: Developing Solid Oral Dosage Forms

  • Part I: Theories and Techniques in the Characterization of Drug Substances and Excipients
    1. Solubility of Pharmaceutical Solids
    2. Crystalline and Amorphous Solids
    3. Solid-State Characterization and Techniques
    4. API Solid-Form Screening and Selection
    5. Drug Stability and Degradation Studies
    6. Excipient Compatibility and Functionality
    7. Polymer Properties and Characterization
    8. Interfacial Phenomena
    9. Fundamental of Diffusion and Dissolution
    10. Particle, Powder, and Compact Characterization

    Part II: Biopharmaceutical and Pharmacokinetic Evaluations of Drug Molecules and Dosage Forms
    11. Oral Absorption Basics: Pathways and Physicochemical and Biological Factors Affecting Absorption
    12. Oral Drug Absorption: Evaluation and Prediction
    13. Dissolution Testing of Solid Products
    14. Bioavailability and Bioequivalence
    15. Predictive Biopharmaceutics and Pharmacokinetics: Modeling and Simulation
    16. In Vitro/In Vivo Correlations: Fundamentals, Development Considerations, and Applications

    Part III: Design, Development and Scale-Up of Formulation and Manufacturing Process
    17. Oral Formulations for Preclinical Studies: Principle, Design, and Development Considerations
    18. Rational Design for Amorphous Solid Dispersions
    19. Rational Design of Oral Modified-Release Drug Delivery Systems
    20. Product and Process Development of Solid Oral Dosage Forms
    21. Analytical Development and Validation for Solid Oral Dosage Forms
    22. Statistical Design and Analysis of Long-Term Stability Studies for Drug Products
    23. Packaging Selection for Solid Oral Dosage Forms
    24. Clinical Supplies Manufacture: Strategy, GMP Considerations, and Cleaning Validation
    25. Specification Setting and Manufacturing Process Control for Solid Oral Drug Products
    26. Process Development, Optimization, and Scale-Up: Providing Reliable Powder Flow and Product Uniformity
    27. Capsules Dosage Form: Formulation and Manufacturing Considerations
    28. Design, Development, and Scale-Up of the High-Shear Wet Granulation Process
    29. Process Development, Optimization, and Scale-Up: Fluid-Bed Granulation
    30. Formulation, Process Development, and Scale-Up: Spray-Drying Amorphous Solid Dispersions for Insoluble Drugs
    31. Process Development and Scale-Up: Twin-Screw Extrusion
    32. Development, Scale-Up, and Optimization of Process Parameters: Roller Compaction Theory and Practice
    33. Development, Optimization, and Scale-Up of Process Parameters: Tablet Compression
    34. Development, Optimization, and Scale-Up of Process Parameters: Pan Coating
    35. Development, Optimization, and Scale-Up of Process Parameters: Wurster Coating
    36. Commercial Manufacturing and Product Quality
    37. Emerging Technology for Modernizing Pharmaceutical Production: Continuous Manufacturing

    Part IV: Regulatory Aspects of Product Development
    38. Drug Product Approval in the United States and International Harmonization
    39. Modern Pharmaceutical Regulations: Quality Assessment for Drug Substances
    40. Modern Pharmaceutical Regulations: Quality Assessment for Drug Products