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Testing, Validation, and Regulatory Compliance
Inhalation is the only technical publication devoted exclusively to readers involved in development and production of pulmonary or nasal delivered pharmaceuticals.
General Articles
Nebulizer testing
OINDP device regulation
Risk management for combination products
Simplifying OINDP regulations
Terahertz characterization of lactose
Technical Articles
A novel aerodynamic sizing method for pharmaceutical aerosols using image-based analysis of settling velocities
A practical method for eliminating type I and type II errors when assessing the suitability for continued use of a cascade impactor
Abbreviated Impactor Measurement (AIM) and Efficient Data Analysis (EDA) Concepts: A partnership for the assurance of Oral Inhaled Product (OIP) quality
Accuracy in the optical inspection of impactor nozzles—More to it than meets the eye
Addressing the patient-device use interface: Development and laboratory validation of a facemask with anatomically-responsive face models
Aerosolized adhesive coating of cascade impactor plates
An overview of general chapter development for oral and nasal drug products (OINDPs) at the US Pharmacopeia (USP): Part 1—Normative chapters <5>, <601>, <602>, <603> and <604>
Analytical instrumentation for solid state characterization of inhalable formulations
Applying QbD principles to device selection
Assessing the role of breathing simulators in OIP testing
Automated Inhaler Testing
Calibrating cascade impactors with particles—Approaches and pitfalls
Chemical-selective imaging of adhesive mixtures for inhalation using coherent anti-Stokes Raman scattering (CARS) microscopy
Comparison between in vitro performance of the Child “Alberta” Idealized Throat and Ph.Eur./USP induction port for the delivery of salbutamol sulfate inhalation aerosol by pressurized metered dose inhaler
Critical evaluation of the revised and new USP chapters for aerosols: <601> and <5> [Pharm Forum 2011; 37(4)]
Design of an inhaler-specific robotic system for laboratory use in early development
Dissolution testing for inhalation formulations
Effect of conditioning on rat lung function measurements and implications for exposure and dose estimation of inhaled drugs
Evaluating the Alberta Throat: An innovation to support the acquisition of more clinically applicable aerosol aerodynamic particle size distribution (APSD) data in oral inhaled product (OIP) development
Evaluating the performance of orally inhaled products in the laboratory: Why clinically appropriate testing is important
Functional respiratory imaging (FRI): Enhancing biomarker sensitivity to expedite drug development
Gaps in statistical approaches to control of delivered dose uniformity throughout product lifecycle
Good practices for Abbreviated Impaction Measurements (AIM) in dry powder inhalers (DPIs)
Human factors and inhalation pharmaceuticals: Manifestations, mitigations and regulatory issues
Implementing the AIM concept
In vitro bioequivalence testing of nasal sprays
In vitro nasal spray characterization
Ingredient-specific particle sizing
Inspecting used impactors—Practice and principles
LC-MSD as a platform for inhalation product development
Measuring the cold freon effect
New cascade impactor software
Obscuring the message: A critical examination of laboratory test methods for orally inhaled products that could lead the user astray: Part 1—Aerodynamic Particle Size Distribution (APSD)
Obscuring the message: A critical examination of laboratory test methods for orally inhaled products that could lead the user astray: Part 2—Total Emitted Mass (TEM) and related metrics
Parameters to consider in software for respiratory drug and device testing
Pharmacoscintigraphy
PK bioequivalence testing when between-batch variability is high: A multiple-batch proposal
Significant advances in laboratory testing of orally inhaled products during the ten-year life of Inhalation
Significant restriction of the delivered dose uniformity criteria in the revised USP Chapter for Aerosols <601>
Spray pattern: A rapid and sensitive early development tool for respiratory drug products
Testing the equivalence of aerodynamic particle size distributions
The Abbreviated Impactor Measurement (AIM) and Efficient Data Analysis (EDA) concepts: Why they are important and how to work with them
The abbreviated impactor measurement concept
The Good Cascade Impactor Practice (GCIP) Concept: A systematic approach to risk management of erroneous measurements in the assessment of inhaler emitted aerosol aerodynamic particle size distributions (APSDs)
The impact of intratracheal aerosol technologies on preclinical pulmonary research
The importance of human factors in inhaler development: The making of PowdAir®
The lung as a dissolution vessel?
The Next Generation Impactor (NGI™)—Manufacturing Control: Part I. Nozzles
The Next Generation Impactor (NGI™)—Manufacturing Control: Part II. Collection Cups and the Critical Jet-to-Plate Distance
The role of the Hydraulic Lung in comparing the performance of dry powder inhalers
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