TY  - JOUR
T1  - Designing Long-Acting Medicines Backward from the Clinical Target Product Profile, Dosing Experience, Real-World Adherence, and Implementation Constraints
A1  - Krzysztof Wiśniewski
A1  - Małgorzata Nowak
A1  - Tomasz Adamczyk
JF  - International Journal of Pharmaceutical Research and Allied Sciences
JO  - Int J Pharm Res Allied Sci
SN  - 2277-3657
Y1  - 2025
VL  - 14
IS  - 2
DO  - 10.51847/kzDSiy6ugm
SP  - 89
EP  - 100
N2  - 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, pharmacodynamic, formulation, process, and supply attributes. The framework treats duration as one constrained design variable within a broader product-fitness architecture. It distinguishes the required therapeutic-exposure window from residual pharmacokinetic persistence, connects potency and dose mass to platform capacity and administration burden, and requires explicit consideration of pain, reversibility, adverse-effect manageability, appointment adherence, persistence, staffing, procurement, storage, and supply continuity. Manufacturing and formulation translation are represented through traceable relationships among drug properties, excipient compatibility, release mechanisms, critical quality attributes, process variables, stability, and analytical methods. Proposed validation gates separate conceptual plausibility from experimental support, in-vitro performance from in-vivo prediction, product similarity from clinical equivalence, and technical feasibility from implementation readiness. Safety, exposure adequacy, critical manageability, and essential implementation feasibility are treated as proposed non-compensable conditions that cannot automatically be offset by a longer dosing interval. The framework is intended to organize multidisciplinary reasoning, expose hidden assumptions, and generate testable development propositions. It does not constitute a validated predictive model, a clinical recommendation, a regulatory standard, or a universally applicable development pathway. Product-specific computational, experimental, manufacturing, clinical, human-factors, and implementation evidence remains necessary before the proposed relationships can support consequential decisions.
UR  - https://ijpras.com/article/designing-long-acting-medicines-backward-from-the-clinical-target-product-profile-dosing-experience-iny6gaybcxj6aph
ER  -