lääkeainelinja
Lääkeainelinja refers to a concept in Finnish pharmaceutical regulation and practice that translates to "active substance line" or "drug substance line." It pertains to the precise specification and control of the active pharmaceutical ingredient (API) within a medicinal product. This includes not only the chemical identity and purity of the API but also its physical characteristics, such as particle size, polymorphism, and solubility, which can significantly impact the drug's bioavailability and therapeutic efficacy.
Regulatory authorities, such as Fimea (the Finnish Medicines Agency), require detailed information about the lääkeainelinja as
Changes to the lääkeainelinja, even minor ones, can have significant implications. If a manufacturer wishes to