Health risk assessments relating to the excipient components of the Voke® formulation
Case study
A novel nicotine replacement device was designed to deliver a pressurised nicotine formulation via a breath operated valve in a cigarette sized medical device. Kind Consumer received a Marketing Authorisation for its lead product, Voke®, in September 2014.
Literature review and in silico prediction of metabolites
Case study
As part of their overall regulatory requirements, the client was asked to provide information on the known or predicted metabolites of a number of ingredients in their products. This formed part of a broader programme of work that bibra conducted for this client.
In silico prediction of genotoxicity and carcinogenicity
Case study
As part of their overall regulatory requirements, the client was asked to provide an assessment of the known or predicted genotoxicity and carcinogenicity of a number of ingredients in their products. Bibra were provided with a list of several substances and asked to carry out this work following the genetic toxicology in silico (GIST) protocol.