This is one in a series of guidances that provides recommendations for applicants preparing theCommon Technical Document for the Registration of Pharmaceuticals for Human Use (CTD). […]
2. COMPARATOR DRUGS SOURCING PROCESS 2.3. Identification of the supply strategy to be used 2.3.1. Selection and communication of a comparator for a clinical trial The […]
A comparator drugs, also known as a reference drug, is one that is included in a clinical study for the purpose of making comparisons of its performance in a defined population.
This is one in a series of guidances that provides recommendations for applicants preparing theCommon Technical Document for the Registration of Pharmaceuticals for Human Use (CTD). […]
2. COMPARATOR DRUGS SOURCING PROCESS 2.3. Identification of the supply strategy to be used 2.3.1. Selection and communication of a comparator for a clinical trial The […]
A comparator drugs, also known as a reference drug, is one that is included in a clinical study for the purpose of making comparisons of its performance in a defined population.