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Pharmaceutical Engineering & Drug Delivery

Automation and Control of Drug-On-Demand Technology

Conference Presentation
AIChE Annual Meeting
Wednesday, October 31, 2012 - 5:15pm-5:45pm
Stimulated by initiatives such as PAT and QbD, the pharmaceutical industry has been focusing on the development of innovative, efficient...

A QbD Approach to the Process Development of Tofacitinib

Conference Presentation
AIChE Annual Meeting
Wednesday, October 31, 2012 - 1:15pm-1:30pm
Tofacitinib citrate (CP-690,550-10) is currently being evaluated for the treatment of rheumatoid arthritis, psoriasis and other diseases. An NDA has...

Optimal Design of Transient Microreactor Experiments

Conference Presentation
AIChE Annual Meeting
Tuesday, October 30, 2012 - 12:30pm-1:00pm
Development of synthetic routes for active pharmaceutical ingredient (API) synthesis is increasingly performed using microreactors, because their use...

A Novel QbD Tool for Statistical Data Analysis

Conference Presentation
AIChE Annual Meeting
Tuesday, October 30, 2012 - 10:15am-10:30am
One of cornerstones of Quality by Design (QbD) is Design of Experiments (DoE). However, in addition to DoE, ICH Q8 (R2) recommends an enhanced...

Modelling of a Filter Drying Process

Conference Presentation
AIChE Annual Meeting
Monday, October 29, 2012 - 5:15pm-5:45pm
Filter drying, also referred to as vacuum contact drying, is a process widely used in the pharmaceutical industry to remove water or organic solvents...

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...

Managing Uncertainty In Design Space

Conference Presentation
AIChE Annual Meeting
Wednesday, October 19, 2011 - 8:00pm
Design of experiments, followed by numeric and graphical optimization, is frequently used by engineers to optimize a process, and to define a design...

Quality by Design for DPIs -A Regulatory Perspective

Conference Presentation
AIChE Annual Meeting
Wednesday, October 19, 2011 - 8:00pm
Inhalation Powders have become an important dosage form in developing products for delivery to the lungs. Since the approval of the first DPI in the...

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...

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...

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...

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...

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