Course Content (Syllabus)
Introduction, ppreclinical testing of active substances, clinical testing of active substances, post-marketing surveillance, environmental risk assessment, GLP/GCP, developing biologicals/hybrid/advanced medicinal products
Keywords
Pharmaceutical research, new drug development, preclinical testing of active substances, clinical testing of active substances, environmental risk assessment
Additional bibliography for study
ΣΥΓΓΡΑΜΜΑ/Book-Principles & Practice of Clinical Research, Glossary of Clinical Trial Terms, PRECLINICAL TESTING STRATEGIES, Guidance for Industry E6 Good Clinical Practice:Consolidated Guidance, Articles, Publications.