محصولات دارویی بیولوژیکی – توسعه و استراتژی Biological Drug Products
- نوع فایل : کتاب
- زبان : انگلیسی
- نویسندگان : Wei Wang and Manmohan Singh
- چاپ و سال / کشور: 2014
- تعداد صفحه : 746
Description
Biological Drug Products: Development and Strategies
This book overviews the fundamental aspects, challenges, and strategies for developing a variety of biological drugs -- a large and growing segment of the pharmaceutical industry. Contributing authors discuss the development process, safety and clinical assessments, manufacturing, regulatory and intellectual property issues. Following this opening, the major classes of biologics are discussed: proteins and peptides, vaccines, oligonucleotides, and gene and regenerative medicines. A concluding section details administration and delivery routes and systems. The book incorporates both lessons learned and future directions to make for a valuable resource and reference for pharmaceutical scientists involved in the dynamic field of biologics
This book overviews the fundamental aspects, challenges, and strategies for developing a variety of biological drugs -- a large and growing segment of the pharmaceutical industry. Contributing authors discuss the development process, safety and clinical assessments, manufacturing, regulatory and intellectual property issues. Following this opening, the major classes of biologics are discussed: proteins and peptides, vaccines, oligonucleotides, and gene and regenerative medicines. A concluding section details administration and delivery routes and systems. The book incorporates both lessons learned and future directions to make for a valuable resource and reference for pharmaceutical scientists involved in the dynamic field of biologics
