Description
This guidance describes the three in vitro tests required in support of the in vivo evaluation of the test product.
Scope & Applicability
Product Classes
4Data and specifications similar to that requested for Metaproterenol Sulfate Inhalation Aerosol should be submitted.
The usual single dose for Albuterol Inhalation Aerosol is two sprays.
Metered Dose Inhalers (MDI); Guidance focuses on in vitro testing for these specific drug delivery systems.
highest degree of concern for packaging interaction; Listed in Table 2 as a common class of drug product requiring suitability considerations.; metered dose inhalers
Stakeholders
1Prepared by: Wallace P. Adams... Division of Bioequivalence
Regulatory Context
Attributes
5Measurement of potency for biological products
A log normal distribution curve should be prepared and the MMAD and GSD should be reported
A log normal distribution curve should be prepared and the MMAD and GSD should be reported
tabulate the cumulative percentage of drug less than the stated diameter versus the aerodynamic particle diameters
minimum number of filled canisters of the final product is 5,000 units
Related CFR Sections (1)
- 21CFR10.90§ 10.90 Food and Drug Administration regulations, recommendations, and agreements.
(a) Regulations. FDA regulations are issued in the Federal Register under § 10.40 or § 10.50 and codified in the Code of Federal Regulations. Regulations may contain provisions that will be enforced as legal requirements, or which are intended only as guidance documents and recommendations, or both.Read full regulation →
See Also (4)
- Topical Dermatologic Corticosteroids: in Vivo Bioequivalence (Status: Final)
- CVM GFI #57 Preparation and Submission of Veterinary Master Files (Status: Final)
- SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (Status: Final)
- Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use (Status: Final)