OINDP and Topicals

Resources

A. Orally Inhaled and Nasal Drug Products (OINDPs)

  1. Valet O, Lankers M, Adi H, Traini D, Young PM. The Use of High Throughput Raman Microscopy for the Concurrent Size Determination and Chemical Characterization of Inhalation Particles Respiratory Drug Delivery 2010. Volume 3, 2010: 763-768.

  2. Traini, D., Adi, H., Valet, O. K., & Young, P. M. (2012). Preparation and evaluation of single and co-engineered combination inhalation carrier formulations for the treatment of asthma. Journal of Pharmaceutical Sciences, 101(11), 4267–4276.
    Early demonstration of expertise in inhalation drug delivery and particle engineering — highlighting SizeID.bio’s scientific heritage.

  3. Krapf, L., Laskina, O., & Valet, O. (2017). Fast Approach for Chemically Specific Particle Size Distribution of Active Pharmaceutical Ingredients in Nasal Sprays Ranging from Submicron Particles to Agglomerates. RDD Europe 2017: 299–304.
    First presentation of submicron-to-agglomerate API PSD analysis in nasal sprays, proving feasibility and regulatory relevance of CSPS.

  4. Guo, C., Ren, Q., Holtgrewe, M., et al. (2018). Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective. AAPS Journal 20, 89.
    Landmark FDA acceptance of MDRS data for Nasonex generic — replacing clinical endpoint studies with in vitro evidence.

  5. Zhang, X., Xu, H., et al. (2021). In Vitro Characterization of Nasal Suspension Drug Products: Regulatory Considerations. Journal of Pharmaceutical Sciences, 110(6), 2415–2428. ScienceDirect link.
    Summarizes FDA regulatory expectations for nasal suspensions, highlighting API PSD and dissolution as critical quality attributes.

  6. Farias, G., Shur, J., Price, R., et al. (2021). A Systematic Approach in the Development of the Morphologically-Directed Raman Spectroscopy Methodology for Characterizing Nasal Suspension Drug Products. AAPS PharmSciTech 22, 167.
    Shows how MDRS links API particle size distribution with dissolution performance — reinforcing the weight-of-evidence approach.

  7. Virden, A. (2025). Method Development Guidance for Nasal Spray Analysis using MDRS. Malvern Panalytical Technical Note TN250318.
    Outlines industry-standard MDRS workflows — but also their limitations (<1 µm gap, reliance on orthogonal methods). Highlights where SizeID.bio closes the gap.

  8. FDA CDER (2025). Product-Specific Guidances for Generic Drug Development (PSGs).
    The latest PSGs explicitly outline in vitro-only BE options for complex nasal suspensions — making in vitro datasets central to ANDA success.

B. Topical and Ophthalmic Products

  1. FDA (2019). Dexamethasone/Tobramycin Ophthalmic Suspension NDA 50818 Review.
    Example dossier showing how in vitro data (particle size + dissolution) carried significant weight in FDA review for a complex ophthalmic product.

  2. EMA (2022, draft). Guideline on Quality and Equivalence of Topical Products (EMA/CHMP/QWP/708282/2018 Rev. 2).
    Outlines EMA’s move toward in vitro equivalence for dermal and ophthalmic products — harmonizing with FDA’s in vitro-first approach.