Human lung deposition data: the bridge between in vitro and clinical evaluations for inhaled drug products?
Regulatory dossiers for new inhaled drug products generally contain in vitro data, which assess delivered dose and particle size distribution, together with clinical efficacy and safety data. Human lung deposition data may be generated using radionuclide imaging techniques or appropriate pharmacokinetic methods, and can act as a 'bridge' via which a seamless transition can be made between in vitro testing in the laboratory and efficacy/safety testing in the clinic. By enabling informed decisions to be made about the evaluation of new devices or formulations in man, lung deposition data permit a long and expensive clinical trials programme to be commenced with much greater certainty of a successful outcome. Human lung deposition data should be considered for supplementing the information required for regulatory dossiers.
Newman
S P
SP
Pharmaceutical Profiles Ltd, Mere Way, Ruddington Fields, Nottingham NG11 6JS, Ruddington, UK. snewman@pharmprofiles.co.uk
Wilding
I R
IR
Hirst
P H
PH
D000280:Administration, Inhalation; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D002986:Clinical Trials as Topic / Q000379:methods; D016503:Drug Delivery Systems / Q000379:methods*; D006801:Humans; D008168:Lung / Q000378:metabolism*; D008297:Male; D009330:Nebulizers and Vaporizers; D010316:Particle Size; D011208:Powders / Q000008:administration & dosage / Q000493:pharmacokinetics*
D018927:Anti-Asthmatic Agents; D011208:Powders