31. March 2018
While some drug innovations are the result of surprises during research phases, a surprise that occurs during development--such as formulation or manufacturing problems--could result in approval delays or failure for a drug product.
To reduce the risk of late-phase surprises, some experts recommend that additional screening efforts in early development can smooth the pathway in later development stages. Developers of promising compounds emerging from drug discovery must balance the need to bett
20. February 2018
Purpose The FDA’s process validation guidance 2011 has rightly resulted in discontinuing the “one size fits all” practice. The guidance aligns process validation with quality by design and quality risk management guidelines. However, the process validation guidance has thrown a challenge with respect to determining the statistically appropriate number of batches for process performance qualification (PPQ) stage. This study reviews various approaches for estimating the number of PPQ...
17. January 2018
Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is
25. November 2017
In this study, within the framework of Quality by Design which is a systemati- cally scientific approach which enables to understand and control the production and formulation variables during the process design and development, different parameters in the formulation and production process were detected and criti- cal process parameters and critical material attributes were determined via risk evaluation methods. Then, different oral disintegrating tablet formulations were prepared and tested b
09. November 2017
This study applied the concept of Quality by Design (QbD) to tablet dissolution. Its goal was to propose a quality control strategy to model dissolution testing of solid oral dose products according to International Conference on Harmonization guidelines. The methodology involved the following three steps.
09. October 2017
This is an example pharmaceutical development report illustrating how ANDA applicants can move toward implementation of Quality by Design (QbD). The purpose of the example is to illustrate the types of pharmaceutical development studies ANDA applicants may use as they implement QbD in their generic product development and to promote discussion on how OGD would use this information in review.
26. September 2017
The lubrication effects of two mixing systems were studied. Shear without MgSt significantly increased blend cohesion.
The effect of shear rate during lubrication was not significant.
The correlations between two mixing systems were established
11. September 2017
The purpose of this work was to develop multi unit particulate formulation using fluid bed processor for the controlled release of Metoprolol succinate and to understand the impact of formulation parameters on the critical quality attributes using a quality-by-design approach.
03. July 2017
While six sigma quality has long been achieved in other industries, it is rarely seen in the pharmaceutical sector.
26. June 2017
The study demonstrates the application of QbD based on historical data for a product at a later development stage – retrospective QbD (rQbD). More specifically, it is investigated the root-cause for the observed slower drug release in Orodispersible Films (ODFs) during storage.