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AERODYNAMIC PARTICLE SIZE DISTRIBUTION (APSD)

APSD

The Aerodynamic Particle Size Distribution (APSD) Working Group's overarching goal is to determine and publicize best scientific approaches for APSD measurements (such as by CI) in the context of characterization, change and control of OINDP.

Currently, the APSD WG is completing an experiment to further study the ability of efficient data analysis (EDA) to detect changes in APSD of a metered dose inhaler (MDI). The experiment is being conducted in parallel in three different laboratories.


A subgroup of the APSD WG is also developing best practices for abbreviated impactor measurement (AIM) testing of dry powder inhalers (DPIs).

The APSD WG will present a poster at DDL 2024.  A copy of the abstract is available here.

Cascade Impaction Tutorials

Click this link to acess all Cascade Impaction Tutorials.

PRODUCT QUALITY DEMONSTRATION
STRATEGY (PQDS)

The overall objectives of the PQDS Knowledge Network (KN) are to explore improved methods for PQDS control; equip companies for successful discussion of appropriate PQDS controls with regulators; monitor, report on, analyze and react to ongoing developments affecting PQDS controls in OINDPs, including those in regulatory guidances, pharmacopeial chapters, ISO standards, conference presentations and published articles; and, as necessary, prepare comments on proposed standards and regulations affecting PQDS controls for OINDP.

The current focus of the PQDS KN is discussing PQDS approaches and promote them through publications, presentations, and ccomments to guidelines and pharmacopeial chapters. 

Publications, including work by the PQDS Working Group (WG) and its predecessors (Deliver Dose Uniformity (DDU) WG, and Dose Content Uniformity (DCU) WG can be found on the Publications page.

PQDS

ANALYTICAL METHODS LIFECYCLE MANAGEMENT

The Analytical Methods Lifecycle Management Knowledge Network tracks and discussed ICH guidelines related to analytical methods lifecycle management, seeking to provide input from the OINDP perspective.  Coordinates with other IPAC-RS groups (e.g., PQDS, APSD) to discuss Established Conditions as applied to OINDP methods, prepares comments, and publicizes IPAC-RS positions in this area, as appropriate.

Analytical Methods
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