Non-human in vitro and in vivo taste-evaluation tools are very useful for pre-formulation, quality control and screening of formulations.
Issue of formulations quality can be further complicated by the fact that exposure of good quality drugs to light, heat, and humidity through inadequate storage may result in deterioration and complicate their classification as counterfeit or substandard.
Despite these market disincentives for pharmaceutical manufacturers, fortunately, important advances have recently been made in the development and production of pediatric ARV formulations quality-certified by the World Health Organization (WHO) Prequalification Progamme [ 8], the United States (US) Food and Drug Administration FDAA) [ 9, 10], or other stringent regulatory authorities.
To optimize this formulation a quality target product profile was established in which critical quality attributes (CQAs) such as mechanical properties and disintegration time were defined and quantified.
In this formulation, the quality of the results depends on both the chemical model term and the quality of the experimental data.
NIRS is sensitive to changes in coating formulation, the quality of a coating excipient (hydroxypropyl methylcellulose), and coating time.
The formulation facilitates quality control based on sampling of indirect information about the condition of the considered components.
Knowledge of the excipient percolation threshold allows a more rational design of swellable matrices, according to the guidelines of the regulatory authorities concerning science-based formulation and quality by design.
And, of course, Navigenics is equally relentless about the privacy and security of the genetic data they collect.
This should include the analytical lab, the formulation lab, quality assurance, and the Study Director (7).
