Biosimilars : Regulatory, clinical, and biopharmaceutical development
- المؤلف
- Hiten J. Gutka, Harry Yang, Shefali Kakar
- سنة النشر
- 2018
- الناشر
- Springer
- لغة الملف
- انكليزي
- نوع الملف
- Book
- تصنيف الكتاب
- Medical Science
- تحميل الكتاب قراءة الكتاب
Provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development.
الكلمات المفتاحية: Pharmacy / Pharmaceutics / Pharmaceutical technology / Pharmaceutical chemistry / Therapeutics / Quality by design / Biologics / Preclinical safety / Chemistry and manufacturing controls (CMC) / Analytical Similarity / Biosimilars
