Integrated Pharmaceutics - Applied Preformulation, Product Design, and Regulatory Science (2nd Edition)

Pharmaceutics refers to the subfield of pharmaceutical sciences that develops drug delivery products or devices to optimize the drug's performance once administered. This multidisciplinary field draws on physical chemistry, organic chemistry, and biophysics to generate and refine these crucial...

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Bibliographic Details
Main Authors Al-Achi, Antoine, Gupta, Mali Ram, Stagner, William Craig
Format eBook Book
LanguageEnglish
Published Hoboken, NJ John Wiley & Sons 2023
Wiley
John Wiley & Sons, Incorporated
Wiley-Blackwell
Edition2nd ed
Subjects
Biopharmaceutics
Chemistry, Pharmaceutical
Dosage Forms > standards
Drug and Narcotic Control
Drug Design
Drugs
Drugs-Dosage forms
Pharmaceutical chemistry
Pharmaceuticals
Pharmaceuticals, Cosmetics & Toiletries
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Cover

Table of Contents:
  • Title Page Prefaces Table of Contents 1. Mathematical Concepts 2. Thermodynamics 3. Solubility and Dissolution 4. Biological Aspects of Formulations 5. Interfacial Properties 6. Adsorption Phenomenon 7. Rheological Principles 8. Chemical Stability and Shelf-Life Determination 9. Particle Science 10. Basic Statistics and Design of Experimental Concepts 11. Formulation Development Concepts 12. The Product Design Process 13. Tablet Product Design 14. Capsule Product Design 15. Dispersed System Product Design 16. Aerosol Product Design 17. Sterile Injectable Product Design 18. Ophthalmic Product Design 19. Transdermal Product Design 20. Oral Modified-Release Product Design 21. Regulatory Practices and Guidelines 22. Regulations for Compounding Pharmacies 23. IND and NDA Phase-Appropriate New Drug Development Process 24. Biological, Biosimilar, Generic, and OTC Products 25. Accelerated New Drug Approval and Expedited Access of New Therapies 26. Post-Drug Approval Activities 27. Drug Master Files, EU Dossiers, and API GMP Guidance 28. Commissioning and Qualification 29. Quality Systems and Controls 30. Safety, Toxicology, and Pharmacogenomics 31. Regulatory Science Initiatives for Advancing Public Health 32. Medical Devices 33. Combination Products 34. Dietary Supplements 35. Animal Drugs and Devices Index