OR WAIT null SECS
June 02, 2013
The authors report on the range and distribution of grow-out times for biological indicators exposed to sublethal sterilization processes.
May 02, 2013
The author examines dry dispersion and outlines the related analytical method development.
The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry.
April 02, 2013
The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design space that allows for formulation changes without revalidation.
The miniaturization of preclinical safety assessment studies using a microfluidic chip system and optical microscopy can help reduce compound requirements, time, and costs in formulation development.
March 02, 2013
The authors demonstrate that using supercritical fluid chromatography offers distinct advantages in speed and in clean isolation of the desired peaks.
The authors review developments in wet granulation using a twin-screw extruder.
February 02, 2013
The minimum amount of residue that can be visually detected is demonstrated for a small number of active pharmaceutical ingredients (APIs) on a range of different surface materials.
Even in an industry in which all product development is complicated by the intricacies of human biology, orally inhaled products (OIP) stand out as singularly demanding.
January 01, 2013
The authors discuss the valuable information that can be obtained from indexing and its applications in routine screening and analysis of solid forms.