Home) Article Archive) Subjects) 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