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398 pages • missing pub info (view editions)
ISBN/UID: 9781498750394
Format: Hardcover
Language: English
Publisher: CRC Press
Edition Pub Date: Not specified
Description
Summary: The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate...
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398 pages • missing pub info (view editions)
ISBN/UID: 9781498750394
Format: Hardcover
Language: English
Publisher: CRC Press
Edition Pub Date: Not specified
Description
Summary: The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate...