Proveris Scientific

Advancing the Science
of Nasal and Inhaled
Drug Delivery

Triangle

Proveris by Design

Lab Studies accelerate product development

Proveris offers a number of essential studies that help drive successful
nasal and orally inhaled drug delivery by bridging the gaps between
patient usage, device performance, and formulation in order to
bring a better Product to market more quickly.

A summary of our Proveris by Design Lab Study offerings
are listed in the table below

Proveris by Design™ Study Descriptions

Offering

Description

Objectives

Patient Usage Ergonometric Studies

Provide critical, quantitative information on how patients in the product’s target age and gender group operate the product

  • Replicate human usage through automated actuation
  • Assess the Product(s) pump/valve delivery and priming specifications
  • For generics, ensure comparable usage to Reference Product
  • Comply with FDA Draft Guidance recommendations
  • Identify any patient usage issues


Reference Product Characterization

Determine the Product’s operating profile through a series of screening experiments to define the critical actuation parameters and develop methods for spray performance tests

  • Evaluate brand performance and manufacturing variability
  • Determine appropriate method(s) to achieve optimal in vitro bioequivalence (BE) correlation of spray performance


Device Component Optimization

Compare the Test Product’s formulation-device component combination(s) to the patient usage and spray performance of the Reference Product

  • Recommend an optimal Test device component combination(s) to achieve in vitro bioequivalence (BE) correlation of spray performance
  • Evaluate and assess variables in formulation-device component combinations


Method Development

Utilize a Patient Usage Study to screen the critical actuation parameters and develop spray pattern and plume geometry methods on the SprayVIEW® Measurement System

  • Deliver robust, reliable methods for accelerated Product development and verification
  • For generics, confirmation of device selection and overall performance


Method Transfer and Verification

Ensures rapid implementation and use of method(s) on new or existing systems

  • Facilitate site to site transfers, new installations, new method deployment on existing systems, and outsourcing to contract service organizations


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