Any ideas on minimizing inconsistency of dose delivery with MDI's in bio studies. Eg contamination, statics and ?inspirational flow rate? Is this at all necessary?
This is tough, when I worked in this are we had to develop much of our equipment and used a half dozen methods. I think you need to find a CRO that has a focus on this type of dosage form. The systems we did use were base on what you'd expect - automating the dispensing and capturing/weighing what was released. Some things are not easy.
I think you may benifit from this:
Guideline on the Requirements for clinical documentation for Orally Inhaled products (OIP) Including the Requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of ASTHMA and Chronic Obstructive Pulmonary disease (COPD) in Adults and For use in the treatment of Asthma in children and adolescents CPMP/EWP/4151/00Rev1, 22 January 2009 European Commission, Brussels, ENTR/CT 3, Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use, Revision 2, April 2006
ot this :
Guideline On The Investigation Of Bioequivalence. Committee For Medicinal Products For Human Use (Chmp), European Medicines Agency (ema), Doc. Ref.: CPMP/EWP/QWP/1401/98 Rev. 1/ Corr, London, 20 January 2010.
Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf
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