BIOSIMILAR DRUG PRODUCT DEVELOPMENT
Laszlo Endrenyi, Dr. Paul Declerck, Shein-Chung ChowWhen a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.
კატეგორია:
წელი:
2017
გამოცემა:
1
გამომცემლობა:
CRC Press
ენა:
english
გვერდები:
487
ISBN 10:
1498718795
ISBN 13:
9781498718790
სერია:
Drugs and the Pharmaceutical Sciences
ფაილი:
PDF, 10.50 MB
IPFS:
,
english, 2017