Pharmacokinetic (PK) biosimilarity and bioanalytical research study for a generic medicinal product intended for the treatment of diabetes.

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This is a summary of the procurement based on the submitted documents: # Procurement Object * Subject: Pharmacokinetic (PK) biosimilarity and bioanalytical study for generic medicinal products for the treatment of diabetes (PharmIdea Semaglutide 2.68 mg/ml vs Ozempic®). * Technical requirements: * Study design: single-dose, open-label, laboratory-blind, randomized, two-sequence, two-drug, two-period crossover study. * Includes: protocol development, preparation of documentation for regulators/ethics committee, clinical phase, bioanalytical services, data management, pharmacovigilance, statistical analysis, and final report…
 
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940344-1-Teh-Spec-SEMAG-Biosimilarity-research-2026-05-28-FIN3-docx.pdf

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