Issue 2 Volume 14 (2025)

Pharmacogenomics can identify inherited determinants of drug disposition, response, and toxicity, but genotype alone cannot specify an optimal treatment for a patient whose functional phenotype, disease state, concomitant therapy, prior exposure, therapeutic priorities, and available options change over time. This Original Causal Decision Architecture Article proposes a Causal Precision Pharmacotherapy Decision Architecture that separates germline information from baseline functional phenotype,

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Pharmaceutical formulations are commonly described through composition, manufacturing specifications, critical quality attributes, and stability endpoints. Although these descriptions are necessary, they may inadequately represent products whose molecular organization, physical state, processability, release behavior, and in-use performance depend on the sequence of conditions experienced throughout the product lifecycle. This Original Dynamic-Systems Theory Article proposes that a pharmaceutica

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Advanced pharmaceutical formulations increasingly arise through interactions among material science, computational design, manufacturing technology, biopharmaceutic modelling, and patient-use requirements. This scoping review maps the concepts, technologies, evidence types, development stages, and translational interfaces represented across the literature. A PRISMA-ScR-compatible and JBI-informed approach defined broad mapping questions, eligibility boundaries, information sources, screening log

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Nanocarriers are commonly defined by properties measured before administration, yet their biologically operative identity changes as they encounter proteins, lipids, antibodies, cells, extracellular matrices, and intracellular environments. Fragmented reporting of manufactured attributes, acquired coronas, recognition events, tissue exposure, degradation, and clearance prevents these transformations from being traced as one evidence chain. This Original Evidence Architecture Article proposes the

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Stimuli-responsive nanomedicines are often designed as if one pathological cue can reliably identify a disease site and authorize payload release. That assumption is fragile when biochemical signals, vascular access, cellular composition, intracellular trafficking, and treatment response vary among patients, lesions, tissue regions, and time points. This article proposes an adaptive-control architecture that treats programmable release as a partially observable control problem rather than a sing

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Pharmaceutical formulation failure is often investigated through separate assessments of composition, manufacturing process, stability, product performance, or patient use. This fragmented approach can overlook failures that arise only when an excipient attribute encounters a particular process exposure and the resulting dosage form is used under physiologically or behaviourally variable conditions. This article develops an original, non-empirical formulation-risk architecture organized around a

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Nanomedicine is often evaluated through target affinity, tissue accumulation, cellular association, or carrier-triggered release, although none of these observations alone establishes that pharmacologically available drug has reached its intended site of action. This Original Transport Theory Article proposes Compartment-Resolved Delivery Theory as an organizing framework for separating the sequential transport states between administration and intracellular drug availability. The theory represe

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Pharmaceutical formulation development is frequently organized around a dominant technical obstacle, with poor aqueous solubility often treated as the principal variable to be corrected. Although solubility enhancement may improve dissolution or create favorable exposure hypotheses, it does not by itself establish dosage-form viability, because the resulting formulation may remain unstable, difficult to manufacture, unsafe for the intended population, or unacceptable in actual use. This article

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Long-acting medicines are commonly differentiated by how long they maintain drug exposure or permit dosing to be deferred, yet nominal duration alone does not determine whether a product is clinically useful, acceptable, manufacturable, or implementable. This article proposes an original Clinical-Backcast Long-Acting Medicine Design Framework that begins with the clinical target product profile, intended use scenario, dosing experience, and health-system pathway before specifying pharmacokinetic

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Nano- and targeted drug-delivery systems are frequently evaluated through favorable physicochemical attributes, mechanistic plausibility, or localized preclinical performance, although these forms of evidence do not necessarily establish translational readiness. This evidence-mapping review examines how the literature connects material characterization, biological identity, barrier interactions, biodistribution, intracellular delivery, pharmacological efficacy, safety, manufacturing control, and

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Nanomedicine performance is commonly summarized through administered dose, blood pharmacokinetics, organ biodistribution, or average tumor accumulation. These measurements are essential but cannot establish which vascular, stromal, immune, or malignant-cell states encounter a carrier, internalize it, release its payload, or achieve pharmacologically relevant intracellular exposure. This article develops the proposed Cell-State-Aware Targeting Model as an original non-empirical architecture for r

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