Forced degradation study

Gaining information about the degradation (chemical) behavior of an API in the frame of research and development

Therapeutic Modalities:

Biologics, Small Molecules

Development Phases:

Research, Preclinical, Early-phase Clinical, Late-Phase Clinical

Quality Standard:

GMP for early clinical phases and non-GMP (ISO 9001:2015)

Pharmacopoeia:

Various international guidelines (e.g. ICH Q1A, ICH Q1B, ICH Q2B)