Pharmaceutical Engineering & Drug Delivery

QbD In Dry Powder Inhaler Development

Conference Presentation
AIChE Annual Meeting
Wednesday, October 19, 2011 - 8:00pm
Summary Developing products comprising un-bound fine cohesive powders throws up significant challenges. Dry powder inhalers present a prime example...

Scaling up Strategy for Continuous Powder Mixing Process

Conference Presentation
AIChE Annual Meeting
Wednesday, October 19, 2011 - 8:00pm
Scaling up strategy for continuous powder mixing process Yijie Gao, Fernando Muzzio and Marianthi G. Ierapetritou Dept. of Chemical and Biochemical...

CMC Reviewer Expectations for ANDAs Using QbD Approaches

Conference Presentation
AIChE Annual Meeting
Tuesday, October 18, 2011 - 8:00pm
There has been an increase in science and risk-based approaches under the Quality by Design paradigm in new drug submissions to the FDA. There are...

QbD for Generic MR Drug Products

Conference Presentation
AIChE Annual Meeting
Tuesday, October 18, 2011 - 8:00pm
The Office of Generic Drugs ensures the therapeutic equivalence and quality of generic drug products. This is based principally upon a regulatory...

Quality by Design for Generic Drugs

Conference Presentation
AIChE Annual Meeting
Monday, October 17, 2011 - 8:00pm
To facilitate the implementation of Quality by Design (QbD) for abbreviated new drug application (ANDA), Office of Generic Drugs (OGD) has developed...

FDA Perspective On QbD for Analytical Methods

Conference Presentation
AIChE Annual Meeting
Monday, October 17, 2011 - 8:00pm
QbD is a systematic approach to pharmaceutical development and product lifecyclemanagement. QbD provides new opportunities and modern tools to...

Building a Better Biofuel Production Platform

Conference Presentation
AIChE Annual Meeting
Monday, October 17, 2011 - 8:00pm
Building a Better Biofuel Production Platform: Engineering metabolic control techniques to control the photosynthetic cyanobacterium Synechocystis sp...

QUALITY by Design (QBD), Biopharmaceutical Manufacture

Conference Presentation
AIChE Annual Meeting
Monday, October 17, 2011 - 8:00pm
In the biopharmaceutical industry, consistently manufacturing a safe and high quality protein drug substance can be challenging. Recently, a...

A QbD Approach to Improve Tablet Coating Uniformity

Conference Presentation
AIChE Annual Meeting
Monday, October 17, 2011 - 8:00pm
A combination of analytical and statistical methods is used to improve a tablet coating process guided by quality by design principles. A solid...

Automation and Control of Drug-On-Demand Technology

Conference Presentation
AIChE Annual Meeting
Sunday, October 16, 2011 - 8:00pm
After the implementation of initiatives such as PAT and QbD, there has been a drive towards efficient manufacturing in the pharmaceutical industry...

QbD - It's Not Just for Breakfast Anymore

Conference Presentation
AIChE Annual Meeting
Sunday, October 16, 2011 - 8:00pm
We are approaching the ten-year mark for the Quality by Design initiative in the pharmaceutical industry. Much has been accomplished and demonstrated...

Can A Design Space Be Built On Material Attributes Alone?

Conference Presentation
AIChE Annual Meeting
Wednesday, November 10, 2010 - 7:00pm
In April, 2009, the PhRMA Drug Product Technical Group sponsored an industry workshop to explore the practicality and limitations of defining a...

Mixture DOE and Design Space

Conference Presentation
AIChE Annual Meeting
Wednesday, November 10, 2010 - 7:00pm
Present a case study on mixture DOE involving five components used to formulate a pharmaceutical tablet. The goal is to achieve a sustained release...

QbD for Generic Drugs: Oral Suspensions

Conference Presentation
AIChE Annual Meeting
Sunday, November 7, 2010 - 7:00pm
The presentation will be focus on the approach for systematic development of oral suspensions. Suspension is a complex dosage form in which coarse...

QbD in Generic Drug Development: PAT Application

Conference Presentation
AIChE Annual Meeting
Sunday, November 7, 2010 - 7:00pm
A generic drug product is pharmaceutically and therapeutically equivalent to a Reference Listed Drug (RLD) product. It meets the same requirements...

Quality by Design for Generic Drugs: Overview

Conference Presentation
AIChE Annual Meeting
Sunday, November 7, 2010 - 7:00pm
Quality by design is an essential part of the modern approach to pharmaceutical quality. But there is uncertainty in the generic drug industry about...

Quality by Design in Pharmaceutical Development

Conference Presentation
AIChE Annual Meeting
Sunday, November 7, 2010 - 7:00pm
More than 70% of the prescriptions in the US are now filled with generic products, and therefore, the industry has the responsibility to continue to...
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