03.09.21 Incorporating Excipients Into QbD Studies For Drug Development An Introduction
Orphan drugs are notorious for their high costs and risk factors, which are attributed to smaller patient pools and higher development and launch costs.
Attend this webinar to learn more about key trends that are causing the rise of orphan drug indications, fast-tracking early development phases that will lead to commercial success, and more!
By Brian Carlin (DFE Pharma), Chris Moreton (FinnBrit Consulting), Dave Schoneker (Black Diamond Consulting), Katherine Ulman (KLU Consulting), and Joseph Zeleznik (IMCD)
This article is the first in a three-part series based on information from the new guide, “Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design,” published by the International Pharmaceutical Excipients Council Federation. Topics covered include measuring the impact of excipient variabili
02.23.21 Cleaning Of Multipurpose API Plants: 9 Rules To Follow
Orphan drugs are notorious for their high costs and risk factors, which are attributed to smaller patient pools and higher development and launch costs.
Attend this webinar to learn more about key trends that are causing the rise of orphan drug indications, fast-tracking early development phases that will lead to commercial success, and more!
By Grant Mordue
Cleaning validation continues to be a hot topic during regulatory inspections and industry discussions. The cleaning required in an API plant between one manufacturing process and the next can present a huge challenge, particularly when multipurpose plants are used.