Pharmaceutical Engineering: A Primer for Advanced Process Development
Editat de René Holm, Noor Al-Rifai, Ashish Kumaren Limba Engleză Paperback – iul 2025
- Features engineering principles of pharmaceutical drug product processes
- Includes development and scale-up of pharmaceutical drug product processes
- Defines a robust process via science and engineering-based principles
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Specificații
ISBN-13: 9780443156984
ISBN-10: 0443156980
Pagini: 300
Dimensiuni: 191 x 235 mm
Greutate: 0.45 kg
Editura: ELSEVIER SCIENCE
ISBN-10: 0443156980
Pagini: 300
Dimensiuni: 191 x 235 mm
Greutate: 0.45 kg
Editura: ELSEVIER SCIENCE
Cuprins
Section 1: The Basics 1. Introduction 2. General introduction to the field of drug product design and development, including current challenges and recent trends. 3. Regulatory considerations for pharmaceutical process development 4. A description of ICH Q8 (R2) in the relevant context, including process requirements, QbD options and experimental/computational approaches, as well as a description of pharmaceutical process validation 5. Engineering fundamentals 6. The basic components needed to understand and build an engineering approach to a pharmaceutical drug product process, including and not limited to: material and energy balances, heat and mass transfer, dimensional analysis, flow of fluids and powders, scale-up approaches and workflows. This will be an introductory chapter and will be covered in more detail in section 2. 7. In process analysis 8. A description of some of the general analytical options that can be used for experimental characterization of drug product processes and the link to subsequent chapters, including the PAT regulatory status. The analytical principles behind common measurements across the different unit operations will be presented here Section 2: Unit Operations 9. Mixing processes 10. Conventional dispersed systems – suspensions and emulsions 11. Advanced drug delivery systems - microparticles, liposomes, LNP and similar platforms 12. Lyophilization 13. Capsule filling – liquid 14. Engineering of sterilization processes