As the pace of product development accelerates, the approach to dissolution-method development must advance beyond a manual method and an assay. A natural progression of the method-development process ...

Missed or late calibration dates can accumulate, and even if the equipment is labelled appropriately, it can suggest poor management of resources and priorities. Good manufacturing practice (GMP) ...

Dissolution and drug release tests are directly relevant to the safety and efficacy of many common pharmaceutical dosage forms. To achieve reliable and reproducible results, analysts must understand ...

Distek, Inc., a leading manufacturer of laboratory testing instruments for the pharmaceutical and biotechnology industry, as well as an experienced provider of validation and qualification services, ...

Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.