Article
OSD Specifications — Dissolution, Hardness, Friability, and the Evidence Package for Acceptance Criteria
A specification table in 3.2.P.5 is not a list of limits — it is a collection of regulatory arguments, each of which must be defended by data. When…
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Article
OSD Specifications — Dissolution, Hardness, Friability, and the Evidence Package for Acceptance Criteria
A specification table in 3.2.P.5 is not a list of limits — it is a collection of regulatory arguments, each of which must be defended by data. When…
Article
Blending Homogeneity and Content Uniformity — ICH Q6A Criteria and the Statistical Strategy for Low-Dose Tablets
For a 5 mg tablet where the API is 2.5% of the tablet weight, blend uniformity is not a process control — it is the single most consequential…
Article
Controlled Release Matrix Systems — Polymer Selection, Release Mechanism, and the 3.2.P.2 Package
HPMC hydrophilic matrix tablets are the most common controlled release platform in oral solid dosage form development — and the most commonly documented without the scientific argument that…
Article
Modified Release Oral Dosage Forms — IVIVC Requirements and the Regulatory Strategy for Extended Rel
The dissolution specification for an immediate release tablet is fundamentally a quality control tool — it confirms that the tablet disintegrates and releases the drug quickly. The dissolution…
Article
Dissolution Method Development — BCS Framework Applied to IND-to-NDA Method Selection
The dissolution method you choose at IND is almost never the dissolution method that survives to NDA. The IND method is selected for analytical simplicity. The NDA method…
Article
Immediate Release Tablet CMC — The 3.2.P.2 Pharmaceutical Development Package That Survives FDA Chemistry Review
The 3.2.P.2 section of an immediate release tablet NDA is not a formulation history document — it is a scientific argument. When the 3.2.P.2 is written as a…
Article
Regulatory Harmonization for Polymer Nanoparticle Drug Products — Navigating FDA-EMA Divergence and ISO-TC 229 Standards
A polymer nanoparticle CMC package built entirely to FDA's expectations will not automatically satisfy EMA, and the reverse is equally true — the two agencies diverge on protein…
Article
Regulatory Harmonization for Polymer Nanoparticle Drug Products — FDA, EMA, ICH, and ISO Nanomedicine Standards
The regulatory frameworks that govern polymer nanoparticle drug products at FDA and EMA were developed largely in parallel, each authority issuing its own guidance and reflection papers without…
Article
Exosome and Extracellular Vesicle Drug Delivery — The CMC Regulatory Path Through CBER
Exosomes and other extracellular vesicles occupy one of the most jurisdictionally ambiguous positions in FDA regulatory science: are they biological products regulated by CBER as cell-derived therapeutics, or…
Article
Exosome and Extracellular Vesicle Drug Delivery — CMC at the Biologic-Nanomedicine Interface
Exosome and extracellular vesicle drug delivery programs sit in a regulatory space FDA has not fully mapped — between the CDER nanomedicine framework, where particle size, encapsulation efficiency,…
Article
Inorganic-Organic Hybrid Nanoparticles — CMC Considerations for Iron Oxide, Silica, and Gold NP Drug Products
Iron oxide nanoparticle drug products present a CMC regulatory paradox: the iron is the drug — contrast enhancement or hyperthermia activity depends directly on iron content per dose…
Article
Inorganic-Organic Hybrid Nanoparticles — CMC Classification Strategy for Iron Oxide, Gold, and Mesoporous Silica Drug Products
Iron oxide nanoparticles, gold nanoparticles, and mesoporous silica nanoparticles share a regulatory question that polymer and lipid nanoparticle CMC teams never have to answer: is the inorganic core…
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