תמונות העטיפה

Technology Transfer Drug Product Manufacturing Process /

Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guida...

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שמור ב:
מידע ביבליוגרפי
Main Authors: Pazhayattil, Ajay Babu (Author), Sharma, Sanjay (Author), Philip, Joe Paul (Author), Gischewski-Silva, Michelle (Author), Ingram, Marzena (Author)
מחבר תאגידי: SpringerLink (Online service)
פורמט: אלקטרוני ספר אלקטרוני
שפה:אנגלית
יצא לאור: Cham : Springer International Publishing : Imprint: Springer, 2023.
מהדורה:1st ed. 2023.
סדרה:AAPS Introductions in the Pharmaceutical Sciences, 10
נושאים:
Pharmacy.
Pharmaceutical chemistry.
Pharmacology.
Drug delivery systems.
Pharmacovigilance.
Pharmaceutics.
Drug Delivery.
Drug Safety and Pharmacovigilance.
גישה מקוונת:https://doi.org/10.1007/978-3-031-32192-4
תגים: הוספת תג
אין תגיות, היה/י הראשונ/ה לתייג את הרשומה!
תוכן הענינים:
  • Chapter 1: Current Status of Technology Transfer
  • Chapter 2: Quality by Design (QbD) Process Design
  • Chapter 3: Quality Risk Management (QRM)
  • Chapter 4: Technology Transfer Process
  • Chapter 5: Scaling-Up of Solid Orals: Granulation, Drying, Size Reduction, Blending, Compression, and Coating Technologies
  • Chapter 6: Qualification, Continued Process Verification, and Lifecycle Management
  • Chapter 7: Continuous Improvement Case Study: Transforming Legacy Products.

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