Pharmaceutical quality by design : principles and applications /

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Beg, Sarwar, 1987- (Editor ), Hasnain, Md Saquib, 1984- (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: London : Academic Press, [2019]
Temas:
Drug development > Quality control.
Drugs > Design > Quality control.
Drugs > Design.
Quality control.
Drug Design
Quality Control
M�edicaments > D�eveloppement > Qualit�e > Contr�ole.
M�edicaments > Conception > Qualit�e > Contr�ole.
M�edicaments > Conception.
Qualit�e > Contr�ole.
quality control.
MEDICAL > Pharmacology.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Front Cover; Pharmaceutical Quality by Design: Principles and Applications; Copyright; Contents; Contributors; Preface; Chapter 1: Introduction to Quality by Design (QbD): Fundamentals, Principles, and Applications; 1. Introduction; 2. Evolution of QbD concept; 3. Pharmaceutical Quality System: A Newer Quality Trend; 4. ICH Guidelines on QbD and Related Paradigms; 5. Philosophy and Principles of QbD; 6. Stakeholders of QbD; 7. Key Elements and Steps for Execution of QbD; 8. Current Regulatory Perspectives on QbD; 9. QbD as a Lifecycle Approach; 9.1. Preclinical Developmental Phase
  • 9.2. Nonclinical and Clinical Phase9.3. Scale-Up Phase; 9.4. Marketing Approval Phase; 10. Application of QbD in Product Development; 10.1. Development of New and Generic Drug Products; 10.2. Development of Nanopharmaceuticals; 10.3. Development of Biosimilars; 10.4. Development of Analytical Methods; 10.5. Development of Drug Substances; 10.6. Development of Dissolution Methods; 10.7. Development of Bioequivalence Methods; 10.8. Development of Stability Testing Methods; 10.9. Development of Clinical Trial Activities; 11. Lifespan of the QbD Concept in the Industrial Milieu; 12. Conclusion
  • 8.5. Control of the Preparation9. Concerns, Problems, and Queries About QbD; 10. Solutions and Benefits Provided by QbD; References; Chapter 3: Application of Design of Experiments (DoE) in Pharmaceutical Product and Process Optimization; 1. Introduction; 2. A Brief History of Experimental Designs; 3. Evolution of Systematic Quality Approaches; 4. ICH Initiatives and Quality by Design; 5. One-Factor-at-a-Time (OFAT) Approach of Experimentation; 6. Comparison of Traditional OFAT vs Modern DoE; 7. General Considerations on Designing Experiments; 8. Fundamental of Applying DoE
  • 9. Vital Principles of Experimental Designs9.1. Randomization; 9.2. Replication; 9.3. Blocking; 10. Steps in Performing DoE; 10.1. Defining the Problem; 10.2. Establishment of Cause-and-Effect Relationship; 10.3. Factor Screening; 10.4. Selection of the Factor Ranges; 10.5. Selection of the Response Variable(s); 10.6. Factor Optimization; 10.7. Performing the Experiment; 10.8. Factor-Response Confirmation; 10.9. Mathematical Modeling in Experimental Design; 10.10. Statistical Data Analysis; 10.11. Selection of Experimental Designs; 10.12. Types of Experimental Designs

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