Pharmaceutical ERA•Regulatory Toxicology•PDE / OEL
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Pharmaceutical Environmental Risk Assessment

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Golodirsen Environmental Risk Assessment (ERA)

Project-specific environmental risk assessment (ERA) support for human medicinal products and regulatory submissions.

CAS Registry Number
1422959-91-8
FDA UNII
033072U4MZ
PubChem Substance Record
SID 377716578
Molecular formula
C305H481N138O112P25
Molecular weight
8,647.28 Da

Identification sources: The FDA VYONDYS 53 prescribing information reports the molecular formula C305H481N138O112P25 and molecular weight 8,647.28 Da. The PubChem substance record (SID 377716578) and FDA GSRS record are included for cross-reference.

View request basketPrefer email? [email protected]
Phase IPhase II where requiredEU / UK / other markets
Assessment scope

Environmental risk assessment (ERA)

ToxWriter provides environmental risk assessment support for human medicinal products. The assessment may include regulatory exposure screening and, where indicated, further evaluation of environmental fate and effects. Scope is defined by the medicinal product, substance form, route of administration, intended market and available environmental evidence.

ERA services may include

  • Review of product details, substance form, route, use pattern and intended market.
  • Phase I environmental exposure screening under the applicable regulatory framework.
  • Phase II environmental fate and ecotoxicity assessment where indicated by the pathway and evidence.
  • PEC/PNEC risk characterisation, PBT/vPvB review and data-gap analysis where relevant.
Assessment considerations

Factors that determine the assessment scope

The applicable ERA pathway is determined by the product and its use, the requirements of the intended market and the environmental data available for review.

  • Exact active-substance form and product identity.
  • Route, maximum daily dose and use assumptions, where applicable.
  • Intended markets and available environmental data or studies.
Assessment deliverablesThe agreed report presents the assessment pathway, supporting evidence, assumptions, uncertainties and conclusions for the defined product and market.
ERA regulatory framework
ERA background →EMA environmental risk assessment guideline · EU human medicinesMHRA environmental risk assessments in medicines · UK

The EMA guideline sets out the EU framework for environmental risk assessment of human medicinal products. MHRA guidance describes UK expectations; the applicable scope depends on the product and submission context.