Technology Transfer : Drug Product Manufacturing Process (Aaps Introductions in the Pharmaceutical Sciences) / Pazhayattil, Ajay Babu/ Sharma, Sanjay/ Philip, Joe Paul

医薬品製造業と技術移転<br>Technology Transfer : Drug Product Manufacturing Process (Aaps Introductions in the Pharmaceutical Sciences)

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医薬品製造業と技術移転
Technology Transfer : Drug Product Manufacturing Process (Aaps Introductions in the Pharmaceutical Sciences)

Pazhayattil, Ajay Babu/ Sharma, Sanjay/ Philip, Joe Paul

ウェブストア価格 ¥32,437（本体¥29,489）
Springer International Publishing AG（2023/06発売）
外貨定価 US$ 159.99
ポイント 294pt

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製本 Hardcover:ハードカバー版／ページ数 148 p.
商品コード 9783031321917

Full Description

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 guidance. This allows organizations to align their technology transfer activities for all regulated markets. However, there is a need for consensus and direction in approaching technology transfer, particularly in understanding how to manage the scale-up effects to ensure regulatory compliance.
This textbook offers technology transfer solutions and guidance to the pharmaceutical industry. The chapters provide a systematic understanding of applying the technology transfer concepts in pharmaceutical manufacturing, promoting standardization within the industry. Since Stage 1b is not specified in detail within the regulations, pharmaceutical organizations are left to determine the requirementsof the stage. The need to justify the methodologies and utilization of sound science makes it more demanding. The textbook's authors provide innovative solutions for technology transfer challenges, making it a comprehensive reference document. The approaches can be applied to both small-molecule and large-molecule drug product manufacturing segments, addressing the unmet needs of the industry.

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.