Please note, this OEL/ADE monograph also applies to taltirelin hydrate (CAS RN 201677-75-0). Taltirelin hydrate is the orally administered form of taltirelin. Taltirelin, a thyrotropin releasing hormone analog, is indicated for the improvement of ataxia in spinocerebellar degeneration (SCD). Taltirelin is a thyrotropin-releasing hormone (TRH) analog, which mimics the physiological actions of TRH, but with a much longer half-life and duration of effects, and little development of tolerance following prolonged dosing (4). The stable TRH analog taltirelin, which has been shown to pass the blood–brain barrier and be more resistant to enzymatic degradation than TRH, produces supraspinal mediated antinociceptive effects, which are characterized by their modality specificity recruiting distinct descending monoaminergic pathways to exert analgesic effects on thermal and mechanical nociception (5- hydroxytryptaminergic and noradrenergic pathways, respectively) and independent of its effects on the motor system.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
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