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Pharmaceutical Engineering & Drug Delivery

QbD for Generic Drugs: Oral Suspensions

Nov 7, 2010
Umesh Pai
The presentation will be focus on the approach for systematic development of oral suspensions. Suspension is a complex dosage form in which coarse dispersion in which insoluble solid particles (internal phase) is dispersed uniformly throughout the suspending medium (external phase). Strategies for...

QbD for Generic Drugs: A Case Study for Immediate-Release Products

Nov 7, 2010
Zhigang Sun
Quality by design (QbD) is a systematic approach for product and process design and development to ensure predefined product quality. Although the recent ICH guidelines (Q8-Q10) have provided an outline for development of “high quality” pharmaceutical products based on a comprehensive QbD approach...

QbD in Generic Drug Development: PAT Application

Nov 7, 2010
Salah U. Ahmed, Yanming Zu
A generic drug product is pharmaceutically and therapeutically equivalent to a Reference Listed Drug (RLD) product. It meets the same requirements for identity, purity, quality, stability, and complies with the same rigid standards of GMP regulations for manufacturing as the innovator product. In...

Using Qualitative Models to Capture and Demonstrate Process Understanding

Nov 7, 2010
Ian Houson
This presentation will cover how qualitative models can be used to capture and demonstrate process understanding and improve communication between disciplines, across geographical locations, languages and cultures both within, and between, organisations and regulators within a QbD framework. The...

Toward a More Reliable USP Dissolution Testing Apparatus II

Nov 7, 2010
Yimin Wang
In the pharmaceutical industry, dissolution testing is a critical step in quality control and a standard method for assessing batch-to-batch consistency of solid oral drug delivery systems, such as tablets. One of the most widely used dissolution test devices is the UPS Apparatus II (paddle). Even...

QbD for Generic Drugs: Modified Release Drug Products

Nov 7, 2010
Andre Raw
The Office of Generic Drugs ensures the therapeutic equivalence and quality of generic drug product pharmaceuticals. This is based principally upon a regulatory paradigm that requires pharmaceutically equivalent drug products containing the same active ingredient, dosage form, and strength (among...

Quality by Design for Generic Drugs: Overview

Nov 7, 2010
Robert A. Lionberger
Quality by design is an essential part of the modern approach to pharmaceutical quality. But there is uncertainty in the generic drug industry about how the core concepts in ICH Q8(R1) will apply to development of generic drugs. FDA's Office of Generic Drugs has been revising its approaches to...

Quality by Design in Pharmaceutical Development

Nov 7, 2010
Yatindra Joshi
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 provide safe, effective, and affordable medications. In 2009 GPhA initiated a dialogue between the Industry and the US FDA Office of Generics on...

Chemical Engineering in the Pharmaceutical Industry: R&D to Manufacturing

October, 2010
This book deals with various unique elements in the drug development process within chemical engineering science and pharmaceutical R&D. The book is intended to be used as a professional reference and potentially as a text book reference in pharmaceutical engineering and pharmaceutical sciences...

Feed-Forward Process Control Strategy for Pharmaceutical Tablet Development

Nov 11, 2009
Koji Muteki
A feed-forward process control strategy which can compensate for the effect of raw material lot-to-lot variability on final tablet attributes in pharmaceutical tablet development is presented. The approach involves building PLS (partial least squares) models that combine raw material attributes and...

Application of Modeling to Scale-up Liquid Mixing Processes

Nov 11, 2009
Venkat R. Koganti
Scale-up of liquid mixing is usually done empirically without considering the several factors like dissolution theory, equipment differences between scales and so on. In this work we present a systematic way to scale-up liquid mixing processes utilizing both Design of Experiment (DoE) approach to...

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