| Description |
1 online resource |
| Series |
Drugs and the pharmaceutical sciences |
|
Drugs and the pharmaceutical sciences.
|
| Contents |
Introduction : scientific factors in biosimilar drug product development / Laszlo Endrenyi, Paul Declerck, Shein-Chung Chow -- Analytical characterization : structural assessment of biosimilarity / Steven Berkowitz -- Analytical similarity assessment / Shein-Chung Chow, Li Liu -- Characterization of biosimilar biologics : the link between structure and functions / Roy Jefferis -- Manufacturing and process control issues -- quality development of biosimilar medicinal products / Alan Fauconnier, Lyudmil Antonov -- Animal studies / Karen de Smet, Leon van Aerts -- The clinical development of biosimilar drugs / Mark McCamish, Gillian R. Woollett, Sigrid Balser -- Statistical methods for biosimilarity / Shein-Chung Chow, Fuyu Song -- Extrapolation of indications / Jian Wang, Wallace Lauzon, Catherine Njue, Agnes V. Klein -- Interchangeability, switchability and substitution of biosimilars / Paul Declerck, Laszlo Endrenyi, Shein-Chung Chow -- Design and analysis of studies for assessing interchangeability / Shein-Chung Chow, Laszlo Endrenyi -- Role of immunogenicity evaluation for biosimilars / Paul Chamberlain -- Pharmacovigilance of biosimilars / Shehla Hashim, Souleh Semalulu, Felix Omara, Duc Vu -- Patent exclusivities affecting biosimilars in the United States, Canada and Europe / Lynn Tyler, Noel Courage -- Biosimilars in the EU : regulatory guidelines / Sol Ruiz -- Biosimilars and biologics : the prospects for competition / Erwin A. Blackstone, Joseph P. Fuhr, Jr. -- Plant-produced biosimilar products / Kenny K.Y. So, Michael R. Marit, J. Christopher Hall, Michael D. McLean |
| Summary |
"When 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."--Provided by publisher |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Online resource; title from digital title page (viewed on January 14, 2019) |
| Subject |
Drug development.
|
|
Drug approval.
|
|
Biosimilar Pharmaceuticals
|
|
Drug Evaluation
|
|
Drug Approval
|
|
MEDICAL -- Pharmacology.
|
|
Drug approval
|
|
Drug development
|
| Form |
Electronic book
|
| Author |
Endrenyi, Laszlo, editor.
|
|
Declerck, Paul (Professor in pharmaceutical sciences), editor.
|
|
Chow, Shein-Chung, 1955- editor.
|
| ISBN |
9781498718806 |
|
1498718809 |
|
1315119870 |
|
9781315119878 |
|
9781351636650 |
|
1351636650 |
|
9781315119939 |
|
1315119935 |
|
