• Publication Date: 08/01/2008
  • Author(s):
    Bacon, Rachel Scholes, Peter D.
  • Organization(s):
    Pharmaceutical Profiles
  • Article Type: Technical Articles
  • Subjects: Product Development/Formulation, Testing, Validation, and Regulatory Compliance
Bringing the clinical and regulatory benefits of gamma scintigraphy to inhaled product development.

Pharmacoscintigraphy, which combines pharmacokinetic (PK) and gamma-scintigraphic studies, can help confirm the acceptability of inhaled formulations for both local and systemic delivery via the respiratory route by probing the relationships between targeted regional drug deposition profiles and systemic PK data. The direct relationships between deposition of drugs in the lungs and their clinical effectiveness for locally acting products means that lung deposition data can act as a surrogate for the clinical response to inhaled asthma drugs and can demonstrate therapeutic equivalence between products in cases where in vitro data alone are inadequate.

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