Issue 3 Volume 15 (2026)

Virtual screening and molecular-property models increasingly produce ordered candidate lists, yet the numerical precision of a prediction is often treated as if it were equivalent to decision certainty. That interpretation is unsafe because prediction error can arise from noisy reference data, model uncertainty, weak chemical-space support, local structure–activity discontinuities, model disagreement, and miscalibration. This Decision-Science Perspective argues that uncertainty should be represe

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Long-acting injectable drug products are commonly interpreted through their nominal release-controlling material, particle attributes, or in vitro release profile. Such descriptions are useful but incomplete because the administered product does not remain in its pre-injection state. In situ forming systems undergo solvent exchange, phase separation, and structural consolidation; polymeric microspheres hydrate, reorganize, degrade, and erode; crystalline suspensions dissolve within a changing ex

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Precision nanomedicine is often framed as increasingly selective recognition of disease-associated molecular targets or increasingly sophisticated responsiveness to pathological stimuli. Both strategies can fail when the biological state that governs carrier access, transformation, and payload release changes across space or during treatment. Tumor vasculature, extracellular matrix, oxygenation, acidity, enzyme activity, redox balance, immune composition, and stromal organization are neither uni

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Targeted drug delivery is usually framed as a problem of increasing affinity for a desired tissue or cell. That framing is incomplete because an administered carrier is simultaneously exposed to biological compartments that remove, retain, transform, redistribute, or consume it before and after target contact. These competing sinks include the mononuclear phagocyte system, liver and spleen, renal and pulmonary pathways, adsorbed proteins, nontarget cellular populations, and finite receptor pools

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Nanocarrier targeting has often been framed as a problem of increasing affinity for a disease-associated receptor or exploiting preferential vascular permeability. Clinical translation has exposed the incompleteness of that interpretation. A nanocarrier must survive systemic disposition, avoid or tolerate competing biological sinks, reach an accessible tissue compartment, retain a functional biological identity, release or present its payload appropriately, and produce a clinically relevant effe

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Advanced drug-delivery systems are usually evaluated as dosage forms with predefined release characteristics, yet the environments into which they release drug are variable in composition, mechanics, transport capacity, disease state, and time. This perspective argues that a useful next design step is to treat selected formulations as adaptive release systems whose performance is defined by how formulation state changes in response to physiologically or therapeutically relevant conditions. Adapt

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Quantitative structure–activity relationship (QSAR) models increasingly support pharmaceutical prioritization, yet predictive accuracy alone does not establish whether a model is sufficiently interpretable or reliable for a specific decision. Explainability methods may identify molecular features associated with predictions, whereas uncertainty methods estimate confidence, calibration, or susceptibility to error; these functions are related but not interchangeable. A systematic review of literat

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Pharmaceutical technologies increasingly permit modification of dose, dosage-form geometry, release behaviour, administration route, and production location. However, technological flexibility does not necessarily make a medicine patient-centred because the same product may perform differently when confronted with swallowing limitations, developmental or age-related gastrointestinal physiology, dose-adjustment requirements, caregiver-mediated administration, or constrained home-use conditions. T

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Precision pharmacotherapy is often represented as a progression from genotype to phenotype, exposure, and dose. That sequence is useful but incomplete because the genome is comparatively stable whereas the pharmacological system surrounding it is not. Enzyme and transporter activity can be modified by inhibitors, inflammatory signaling, frailty, organ function, pregnancy, and treatment-mediated physiological change. Drug exposure may consequently diverge from the value anticipated from genotype

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Pharmacogenomics is often implemented as though certainty accumulates monotonically from variant detection to prescribing action. In practice, these levels can separate. A genotype may be analytically secure while its functional consequence remains substrate-dependent, altered by copy-number structure or comedication, or incompletely transferable across populations. A gene–drug association may be pharmacologically compelling while the magnitude of clinical benefit remains dependent on comparator

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Biosimilarity is established at a defined point in product development, whereas both reference products and biosimilars continue to evolve after approval through manufacturing changes, site transfers, process optimization, formulation updates, and routine lot-to-lot variation. This creates a temporal problem that is poorly described by a one-time similarity judgment. Yet measurable change should not be equated with clinically meaningful drift: contemporary lifecycle evidence includes both docume

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Biopharmaceutical characterization can now resolve molecular heterogeneity at a level that was inaccessible during earlier generations of therapeutic-protein development. This analytical progress is essential for process understanding, comparability and biosimilarity, but it creates a recurring interpretive problem: an attribute can be measured reproducibly without being equally important to product performance or patient outcome. Treating detectability as a surrogate for criticality risks over-

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Biosimilar switching is evaluated using pharmaceutical, analytical, pharmacokinetic, and clinical comparability, whereas the act of self-injection introduces a separate set of device-dependent and user-dependent conditions. To explain when presentation changes might alter administration consistency despite acceptable biosimilar comparability, and identify observations capable of testing that explanation. This nonempirical multilevel theory integrates published work on biosimilar switching, patie

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Therapeutic messenger RNA (mRNA) is frequently redesigned through synonymous coding substitutions intended to improve stability and expression without changing the encoded amino-acid sequence. Yet RNA persistence, ribosomal translation, nascent-chain folding, and biologically active protein accumulation are distinct outcomes; optimization of one cannot guarantee improvement of the others. This mechanism-based theoretical article integrates experimental and computational evidence on codon choice,

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Parent-drug plasma exposure is frequently used to interpret efficacy, toxicity, and interaction risk, although biotransformation can generate active products with different kinetics, tissue access, and pharmacodynamic actions. The same parent-drug area under the concentration–time curve can therefore correspond to distinct biologically effective exposure histories. To specify when parent-only inference becomes unreliable and develop testable conditions for integrating active-metabolite contribut

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