%0 Journal Article
%T Crossing the Pharmaceutical Translation Gap: A Systematic Review of Evidence Maturity, Reproducibility, Manufacturing Readiness, and Implementation Barriers
%A Erik Van der Meer
%A Lieke Jansen
%A Bram de Vries
%A Sophie Claes
%J International Journal of Pharmaceutical Research and Allied Sciences
%@ 2277-3657
%D 2025
%V 14
%N 4
%R 10.51847/JDgGCLTR7N
%P 89-101
%X Pharmaceutical innovation frequently generates compelling mechanistic, computational, preclinical, or technological findings that do not progress into reproducible, manufacturable, clinically useful, and sustainably implemented products. This systematic review examined how evidence maturity, reproducibility, external validation, manufacturing feasibility, clinical relevance, and implementation conditions jointly shape pharmaceutical translation. A protocol-driven review design was used, with prespecified questions, eligibility criteria, concept-based searches across bibliographic and article-record sources, DOI and journal-status verification, duplicate and version control, structured extraction, design-specific quality appraisal, and qualitative framework synthesis. Meta-analysis was not planned because the reviewed literature encompassed heterogeneous technologies, experimental systems, comparators, outcomes, and stages of development. The evidence indicates that translation readiness cannot be inferred from technical novelty, internal predictive performance, mechanistic plausibility, or isolated proof-of-concept success. Greater maturity is associated with convergent biological evidence, transparent data provenance, replication, external evaluation, fit-for-purpose human relevance, integrated process development, scalable quality control, clinical utility, and compatibility with organizational and patient-care contexts. However, evidence remains uneven across domains. Computational and preclinical studies frequently lack transportable validation, manufacturing studies often evaluate selected platforms or products, and implementation reports may document adoption without establishing patient benefit or sustainability. Cross-domain comparison is further limited by inconsistent terminology, platform-specific criteria, publication bias, and the absence of universally accepted progression thresholds. The review therefore supports a multidimensional and decision-specific interpretation of translation readiness. Progression should depend on the weakest consequential evidence domain rather than the strongest isolated result, while remaining explicitly conditional on the product, intended use, population, manufacturing environment, and implementation setting. 
%U https://ijpras.com/article/crossing-the-pharmaceutical-translation-gap-a-systematic-review-of-evidence-maturity-reproducibili-798prog4w5ji5ku