AN ADAPTATION OF QUALITY CONTROL CHART METHODS TO BACTERIAL VACCINE POTENCY TESTING

A New Control Chart to Monitor Mean Shifts of Bi-Variate Quality Control Processes

Potency Testing of Modified Alum Adjuvant Haemorrhagic Septicaemia Vaccine in Laborlltory and Farm Animais.

Antigenic variation between rabies virus strains and its relevance in vaccine production and potency testing

Comparative Assessment of the Whole-cell Pertussis Vaccine Potency Using Serological and Intracerebral Mouse Protection Methods

One of the most important QC tests of whole-cell pertussis vaccine (WCPV) is potency test. In this regard, mouse protection test (MPT) is the current potency method, which is associated with severe animal distress and large variability in results. The purpose of this study was to assess Pertussis Serological Potency Test (PSPT) as a serological alternative method to intracerebral challenge in M...

Quality-control analytical methods: the quality of sterility testing.

Microbiology, like compounding, is a science that must be demonstrated to show that it is reliable, reproducible, and scientifically sound. Aseptic technique must become second nature to the microbiologist and the compounding pharmacist. With each new drug tested by a quality-control laboratory, there is a responsibility that everything possible is done to ensure that the test result reported i...