Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India

Sau L. Lee, Bhawana Saluja, Alfredo García‐Arieta, +8

The AAPS Journal

Drug SafetyAsthmaRegulatory ApprovalHealth PolicyBioequivalence +6

Novel low molecular weight lignins as potential anti-emphysema agents: In vitro triple inhibitory activity against elastase, oxidation and inflammation

Bhawana Saluja, Jay N. Thakkar, Hua Li, +2

Pulmonary Pharmacology & Therapeutics

AllergyMedicinePotential Anti-emphysema AgentsChemical BiologyPharmacology +3

Predicting Pulmonary Pharmacokinetics from In Vitro Properties of Dry Powder Inhalers

Sharvari Bhagwat, Uta Schilling, Mong‐Jen Chen, +5

Pharmaceutical Research

AsthmaLung DepositionMedicinePulmonary PharmacologyPulmonary Medicine +5

Effect of Device Design and Formulation on the In Vitro Comparability for Multi-Unit Dose Dry Powder Inhalers

Jagdeep Shur, Bhawana Saluja, Sau Lee, +2

The AAPS Journal

AsthmaLung DepositionExcipientsMedicinePharmaceutical Technology +5

Patient Focus and Regulatory Considerations for Inhalation Device Design: Report from the 2015 IPAC-RS/ISAM Workshop

Nicolás Roche, G. Scheuch, J.N. Pritchard, +11

Journal of Aerosol Medicine and Pulmonary Drug Delivery

AsthmaLung DepositionPulmonary CareHealth PolicyPatient Focus +10

Development of an Aerosol Dose Collection Apparatus for In Vitro Dissolution Measurements of Orally Inhaled Drug Products

Robert Price, Jagdeep Shur, William J. Ganley, +7

The AAPS Journal

AsthmaDissolution Rate DifferencesLung DepositionMedicineAerosol Sampling +9

The Influence of Secondary Processing on the Structural Relaxation Dynamics of Fluticasone Propionate

Roberto Depasquale, Sau L. Lee, Bhawana Saluja, +2

AAPS PharmSciTech

Relaxation ProcessEngineeringStructural Relaxation DynamicsSecondary ProcessingFluticasone Propionate +4

Influence of Formulation Factors on the Aerosol Performance of Suspension and Solution Metered Dose Inhalers: A Systematic Approach

Poonam Sheth, Dennis Sandell, Denise S. Conti, +3

The AAPS Journal

AsthmaAerosol PerformanceAerosol TransportAllergyFormulation Factors +5

Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective

Qing Liu, Mohammad Absar, Bhawana Saluja, +5

The AAPS Journal

AsthmaBioequivalence PerspectiveAllergyAllergy MedicineScientific Considerations +3

Can Pharmacokinetic Studies Assess the Pulmonary Fate of Dry Powder Inhaler Formulations of Fluticasone Propionate?

Günther Hochhaus, Mong‐Jen Chen, Abhinav Kurumaddali, +25

The AAPS Journal

AsthmaPharmacokinetic Studies AssessLung DepositionPharmacologyFluticasone Propionate +4