Not only pharmacokineticists get to have fun in the modeling sandbox. Chemists and formulators get to have their fun synthesizing data. Let’s use an example of how dissolution data can be used for modeling. The example is taken from a project to develop a oral modified release drug where the RLD is an immediate release [...]
Archive for August, 2008
Modeling using Dissolution Data
Published August 22nd, 2008 in Formulation Issues and How to:. 0 CommentsWe recently changed the navigation and look of our website (http://www.camargopharma.com/) to show that we are a full-service drug development company. 505(b)(2) drug development is so much more than just regulatory submissions! I was asked to explain what the chart is on the pharmacokinetics services ‘page’:
The chart is a result of pharmacokinetic modeling. Note the [...]
KV’s DESI Guaifenesin Trumped by Adam’s 505(b)(2) Product
Published August 4th, 2008 in News Commentary. 0 CommentsLast week (7/30/2008) , FDA announced that it seized timed-release guaifenesin products from KV Pharmaceutical. In 2002 the FDA determined this DESI product to be a safety hazard to children. The manufacturers, including KV Pharmaceutical (Warning Letters: see page 23) were told to stop manufacturing by November 2003 unless they received NDA approval. Adams Respiratory Therapeutics obtained NDA [...]
FDA announced on August 1, 2008 the user fees for fiscal year 2009 (the U.S. government 2009 fiscal year start on October 1, 2008). The fees are based on PDUFA IV approved last year. The application fee for an application requiring clinical data is $1,247,200, for an application not requiring clinical data or a supplement [...]
Residual Solvents - New FDA Draft Guidance
Published August 7th, 2008 in Formulation Issues and News Commentary. 0 CommentsThe USP established a new test requirement for control of residual solvents in finished dosage forms. The new test is in the General Chapter <467> “Residual Solvents” [Sorry no link - password protected]. The test became official July 1, 2008. In turn, on August 5, 2008 the FDA issued a draft guidance stating that all NDA and [...]