haas-and-partners-specific-safety-issues-fray-200SPECIFIC SAFETY ISSUES

Given the broad experience across therapeutic and product settings,

Haas and Partners have been involved in the assessment and management of a wide range of safety issues including idiosyncratic reactions and those rooted in pharmacologic mechanism. Understanding therapeutic mechanisms allows us to identify issues that may be potential safety concerns and provide proactive approaches to their management. Assessment of safety issues and their management is always undertaken in the context of benefits, risks and available options.

  • Hypersensitivity – anaphylaxis, cytokine release, autoimmune reactions
Carcinogenicity – pre-clinical and clinical findings, post approval surveillance
  • Pregnancy 
– pregnancy exposure registries, teratogenicity
Metabolism – drug interactions, metabolic variants
  • Target organ toxicities – cardiac, hepatic, renal, bone marrow, skin