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03.09.21 -- Incorporating Excipients Into QbD Studies For Drug Development -- An Introduction

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 ....

Jens Christoph Matuszczyk , Pim Hermans , Elina Klijs , Alex Armengol , Kevin Sleijpen , James Faust , Anja Overweel , Melisa Carpio , Robert Smith , Gerhard Greller , Frank Detmers , Janice Abel , Brian Rodenhausen , Sebastian Ruhl , Andy Goll , Jens Rupprecht , Hendrik Adams , Matt Hicks , Maria Lloris , Bernat Busquet , Paul Janszen , John Erdner , Simon Adema , Frederic Baudry , Seeq Corporation , Article Stevanato Group ,

02.23.21 -- Cleaning Of Multipurpose API Plants: 9 Rules To Follow

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. ....

Chantaleg Robles , Alexander Kele , Shantanu Sonparote , David Westman , Oliver Hardick , Jinyu Zou , Sylvia Tsengouras , Brian Scanlon , Kara Faford , Andy Goll , Jason Osman , Matthew Townsend , Tuomo Frigard , John Mcguire , Linnea Troeng , Charles Ross , Isabelle Lafosse , Sharon Nowak , Article Nuaire Inc , White Paper Natoli Engineering Company Inc , Article Ropack Pharma Solutions , Article Promega Corporation , Son Company , Weiler Engineering Inc , Case Study Stevanato Group , Grifols Recombinant Protein ,