- Resolving a few misconceptions when analyzing data from inhaler particle size distribution measurements
- Quality requirements for cascade impactors assigned to batch release testing of a specific drug product; Part III: Implications of Type II error probability
- Inhaled administration of drugs to animals in pharmaceutical research
- Cascade impactor stage groupings: Poor decisions from degraded data
- Point of View: Overcoming barriers to affordability of orally inhaled products while protecting innovation
- The liability of fine particle dose (FPD)
- A clinically relevant approach to assess in vitro bioequivalence for regulatory approval of DPIs: A case study
- Quality requirements for cascade impactors assigned to batch release testing of a specific drug product; Part II: The concept of “sufficient” as applied to impactor quality specifications
- Optimizing the role of automation in variability reduction strategies for delivered dose uniformity (DDU) and aerodynamic particle size distribution (APSD) testing of inhaled drug products
- Quality requirements for cascade impactors assigned to batch release testing of a specific drug product; Part I: A grassroots look
- The regulatory landscape for OINDPs—the biggest shake-up in a generation?
- Point of View: Recommendations to a young scientist to pursue inhalation research
- Defining the dosage strength for labeling of DPIs: Use, limitations and relevance of in vitro data
- An overview of general chapter development for oral and nasal drug products (OINDPs) at the US Pharmacopeia (USP): Part 2—Informative chapters <1601>, <1602>, <1603> and <1604>
- Respirable, engineered, spray-dried dry powders for 505(b)(2) drug product development
- Combined impactor and x-ray diffraction (XRPD) methodology for characterizing polymorph impurities in inhalation powders
- Meeting expectations for FDA nasal spray Q3 structural equivalence
- 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>
- A practical method for eliminating type I and type II errors when assessing the suitability for continued use of a cascade impactor
- Back Page: Humble giant of cascade impactors, Virgil A. Marple; August 16, 1939 to December 24, 2017
- Back Page: A free online tutorial about cascade impaction from the IPAC-RS CI working group
- Back Page: Acoustic emission for characterization of inhaler performance
- Back Page: Modeling paradigms for orally inhaled drugs
- Back Page: Rules in pharmacy and music: More in common than you might believe!
- Back Page: On the design of comparator clinical studies
- The lung as a dissolution vessel?
- The importance of human factors in inhaler development: The making of PowdAir®
- The impact of intratracheal aerosol technologies on preclinical pulmonary research
- 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 abbreviated impactor measurement concept
- The Abbreviated Impactor Measurement (AIM) and Efficient Data Analysis (EDA) concepts: Why they are important and how to work with them
- Terahertz characterization of lactose
- Simplifying OINDP regulations
- Significant restriction of the delivered dose uniformity criteria in the revised USP Chapter for Aerosols
- Significant advances in laboratory testing of orally inhaled products during the ten-year life of Inhalation
- Risk management for combination products
- PK bioequivalence testing when between-batch variability is high: A multiple-batch proposal
- Pharmacoscintigraphy
- Parameters to consider in software for respiratory drug and device testing
- OINDP device regulation
- 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
- New cascade impactor software
- Nebulizer testing
- Measuring the cold freon effect
- LC-MSD as a platform for inhalation product development
- Inspecting used impactors—Practice and principles
- Ingredient-specific particle sizing
- In vitro nasal spray characterization
- In vitro bioequivalence testing of nasal sprays
- Implementing the AIM concept
- Human factors and inhalation pharmaceuticals: Manifestations, mitigations and regulatory issues
- Good practices for Abbreviated Impaction Measurements (AIM) in dry powder inhalers (DPIs)
- Gaps in statistical approaches to control of delivered dose uniformity throughout product lifecycle
- Functional respiratory imaging (FRI): Enhancing biomarker sensitivity to expedite drug development
- Evaluating the performance of orally inhaled products in the laboratory: Why clinically appropriate testing is important
- 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
- Effect of conditioning on rat lung function measurements and implications for exposure and dose estimation of inhaled drugs
- Dissolution testing for inhalation formulations
- Design of an inhaler-specific robotic system for laboratory use in early development
- Critical evaluation of the revised and new USP chapters for aerosols: and [Pharm Forum 2011; 37(4)]
- 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
- 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
- Chemical-selective imaging of adhesive mixtures for inhalation using coherent anti-Stokes Raman scattering (CARS) microscopy
- Calibrating cascade impactors with particles—Approaches and pitfalls
- Automated Inhaler Testing
- Assessing the role of breathing simulators in OIP testing
- Applying QbD principles to device selection
- Analytical instrumentation for solid state characterization of inhalable formulations
- Aerosolized adhesive coating of cascade impactor plates
- Accuracy in the optical inspection of impactor nozzles—More to it than meets the eye
- Abbreviated Impactor Measurement (AIM) and Efficient Data Analysis (EDA) Concepts: A partnership for the assurance of Oral Inhaled Product (OIP) quality
- A novel aerodynamic sizing method for pharmaceutical aerosols using image-based analysis of settling velocities
- Testing the equivalence of aerodynamic particle size distributions
- Spray pattern: A rapid and sensitive early development tool for respiratory drug products
- 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)
- Addressing the patient-device use interface: Development and laboratory validation of a facemask with anatomically-responsive face models