Zobrazeno 1 - 5
of 5
pro vyhledávání: '"Tara Scherder"'
Publikováno v:
Case Studies in Bayesian Methods for Biopharmaceutical CMC ISBN: 9781003255093
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::93dfb0df874c96b97712c7968bac04ff
https://doi.org/10.1201/9781003255093-8
https://doi.org/10.1201/9781003255093-8
Publikováno v:
Case Studies in Bayesian Methods for Biopharmaceutical CMC ISBN: 9781003255093
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::6ffb12712a2684ddd591b9af06f946fc
https://doi.org/10.1201/9781003255093-12
https://doi.org/10.1201/9781003255093-12
Autor:
Tara Scherder, Katherine Giacoletti
Publikováno v:
Bayesian Methods in Pharmaceutical Research ISBN: 9781315180212
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::41bc70a959443f9aca9a00ab8877c1ee
https://doi.org/10.1201/9781315180212-24
https://doi.org/10.1201/9781315180212-24
Publikováno v:
Journal of Biopharmaceutical Statistics. 25:247-259
The concept of quality by design (QbD) as published in ICH-Q8 is currently one of the most recurrent topics in the pharmaceutical literature. This guideline recommends the use of information and prior knowledge gathered during pharmaceutical developm
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::291eb2e31ef2e6585180f304488f5db1
https://doi.org/10.1080/10543406.2014.979197
https://doi.org/10.1080/10543406.2014.979197
Autor:
Eric Rozet, Jean-François Michiels, Tara Scherder, Perceval Sondag, Pierre Lebrun, Bruno Boulanger
Publikováno v:
Journal of biopharmaceutical statistics. 25(2)
Since the adoption of the ICH Q8 document concerning the development of pharmaceutical processes following a quality by design (QbD) approach, there have been many discussions on the opportunity for analytical procedure developments to follow a simil
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b371230b4c620b3cacd18b21b6c46d56
https://pubmed.ncbi.nlm.nih.gov/25357001
https://pubmed.ncbi.nlm.nih.gov/25357001