Zobrazeno 1 - 7
of 7
pro vyhledávání: '"Sheryl Martin-Moe"'
This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define
Autor:
Alavattam Sreedhara, Rita L. Wong, Fredric J. Lim, Sheryl Martin‐Moe, Jagannathan Sundaram, Samir U. Sane
Publikováno v:
Journal of Pharmaceutical Sciences. 100:3031-3043
Quality by design (QbD) is a science- and risk-based approach to drug product development. Although pharmaceutical companies have historically used many of the same principles during development, this knowledge was not always formally captured or pro
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6e873632d1ae3fcc7bd748a97dfca9ce
https://doi.org/10.1002/jps.22545
https://doi.org/10.1002/jps.22545
Autor:
Sheryl Martin-Moe, Carol Nast
Publikováno v:
Quality by Design for Biopharmaceutical Drug Product Development ISBN: 9781493923151
The foundation for success of Quality by Design (QbD) for biologics is in place. QbD practices have already added significant value to developing biologic processes and to a deeper understanding of manufacturing processes. In the case of drug product
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::7a0d721605399436303a826d164b8199
https://doi.org/10.1007/978-1-4939-2316-8_4
https://doi.org/10.1007/978-1-4939-2316-8_4
Autor:
Rohini Deshpande, Sheryl Martin-Moe, Y. John Wang, Susan Hershenson, Tim Osslund, Tahir A. Mahmood
Publikováno v:
Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
The first synthetic drug, acetylsalicylate, produced in 1895 and patented as aspirin [1] (Bayer in 1900), marks the beginning of the modern pharmaceutical industry. Throughout the early to mid-1900s there was significant emphasis on development of sy
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::5e0eb89addd96b6c3609ca88cff0cfee
https://doi.org/10.1002/9780470595886.ch1
https://doi.org/10.1002/9780470595886.ch1
Publikováno v:
International journal of pharmaceutics. 351(1-2)
A pituitary adenylate cyclase-activating peptide (PACAP) analogue (HSDAVFTDNYTRLRKQVAAKKYLQSIKNKRY, P66) was formulated in several non-aqueous solvents in anticipation of improved shelf-life stability. However, the stability of this peptide in these
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ba2883a5ec4897c54d2da8948c1592a0
https://pubmed.ncbi.nlm.nih.gov/17964744
https://pubmed.ncbi.nlm.nih.gov/17964744
Publikováno v:
PDA journal of pharmaceutical science and technology. 58(3)
For the first time, it has been demonstrated that a protein product can be oxidized readily by certain sanitizing agents through vapor transfer not only in a closed system but also in an open environment. The effect of several sanitizing agents on th
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::139c0473e13c842bb75f921a6572b209
https://pubmed.ncbi.nlm.nih.gov/15233252
https://pubmed.ncbi.nlm.nih.gov/15233252
Publikováno v:
Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::c758bb75968d9e3a6fe69b8fcb851279
https://doi.org/10.1201/b13997-15
https://doi.org/10.1201/b13997-15