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The Medicine Maker Hosts Revealing Discussion with Experts from IPEC-Americas on the Importance of Novel Excipients for Pharmaceuticals

New York (PRWEB) March 23, 2022 “Setting the Course for Novel Excipients” saw the panel discuss the unmet needs and challenges in drug formulation and how ....

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Applying QbD To Incorporate Excipients Into Drug Lifecycle Management

Applying QbD To Incorporate Excipients Into Drug Lifecycle Management
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Integrating Excipients Into QbD For Drug Development Understanding Drift Critical Material Attributes

Integrating Excipients Into QbD For Drug Development Understanding Drift Critical Material Attributes
pharmaceuticalonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmaceuticalonline.com Daily Mail and Mail on Sunday newspapers.

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Incorporating Excipients Into QbD Studies For Drug Development — An Introduction

Incorporating Excipients Into QbD Studies For Drug Development â An Introduction
By Brian Carlin (DFE Pharma), Chris Moreton (FinnBrit Consulting), Dave Schoneker (Black Diamond Consulting), Katherine Ulman (KLU Consulting), 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 (IPEC Federation).
1
The International Conference on Harmonization’s (ICH) guidelines related to quality by design (QbD) primarily ICH Q8, as well as Q9, Q10, Q11, and Q12
2-6 are high level and focus on the active pharmaceutical ingredient (API) and finished drug product. Applying API logic to excipients can lead to counterproductive adaptations inconsistent with QbD principles. ....

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