دانلود کتاب بیوژنریک: چشم انداز FDA
Biosimilarity: The FDA Perspective, 1ed

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The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products. The FDA is quite different from other regulatory agencies. With the US providing more than 50% of the worldwide market for these products, every serious manufacturer of biosimilar biological drugs should be targeting US approval of their products. Thus, this book is strictly on FDA approval strategy.

About the Author

Sarfaraz K. Niazi Ph.D,  is Adjunct Professor at the faculty of University of Houston as well Chairman and President of Therapeutic Proteins Inc.

Contents

Chapter 1: Understanding proteins
Chapter 2: The biosimilar landscape
Chapter 3: The FDA regulatory guidance
Chapter 4: Understanding biosimilarity
Chapter 5: Biophamnaceutical tools
Chapter 6: Critical quality attributes
Chapter 7: Safety similarity
Chapter 8: Formulation similarity
Chapter 9: Statistical Approach to Analytical Similarity
Chapter 10: Biosimilarity

قیمت : 3000 تومان
لینک کوتاه : https://bookbaz.ir/?p=102514
نویسنده : Sarfaraz K. Niazi
ناشر : CRC Press; 1 edition
سال انتشار : 2019
زبان کتاب : انگلیسی
نوع فایل : PDF
تعداد صفحات : 436
(ISBN) شابک : 1498750397
قیمت کتاب درآمازون : $132.19
حجم فایل : 6 MB

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