Pharmaceutical Engineering & Drug Delivery

Optimal Design of Transient Microreactor Experiments

Conference Presentation
AIChE Annual Meeting
October 30, 2012
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
October 30, 2012
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
October 29, 2012
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
October 19, 2011
Summary Developing products comprising un-bound fine cohesive powders throws up significant challenges. Dry powder inhalers present a prime example...

Managing Uncertainty In Design Space

Conference Presentation
AIChE Annual Meeting
October 19, 2011
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
October 19, 2011
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...

QbD for Generic MR Drug Products

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

A QbD Approach to Improve Tablet Coating Uniformity

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

Quality by Design for Generic Drugs

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

Automation and Control of Drug-On-Demand Technology

Conference Presentation
AIChE Annual Meeting
October 16, 2011
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
October 16, 2011
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
November 10, 2010
Present a case study on mixture DOE involving five components used to formulate a pharmaceutical tablet. The goal is to achieve a sustained release...

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