c CAS number CAT classification Chemical Abstract Services (CAS) are unique numerical identifiers for chemical elements, compounds, polymers, biological sequences, mixtures and alloys. Biotechnology is the application of biological organisms, systems or process to manufacturing of pharmaceuticals. b Bioequivalence study Biotechnology Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two preparations of a Medicinal Product. International system for classification of medicines maintained by World Health Organisation. Ref: DIRECTIVE 2001/20/EC Anatomic, therapeutic, chemical.
FREE CLINICAL TRIALS PORTLAND TRIAL
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Advance Therapy Investigational Medicinal Products are medicinal products involving cell or gene therapy or tissue engineering. Glossary of s used in EU Clinical Trials Register a Active Substance Active substance of biotechnological origin Active substance of chemical origin Adolescents (12-17 years) Adults (18-64 years) Advanced Therapy IMP (ATIMP) Adverse Event ATC An active substance (AS), is the substance in a medicinal product that is biologically active A product that contains an active substance of biological or biotechnological origin A product that contains an active substance of chemical origin Subjects are aged 12 to less than 18 years. They are not intended as the regulatory definitions and should not be used or substituted for the regulatory definitions and guidelines. 1 EU Clinical Trials Register Disclaimer: The explanations are provided for the benefit of public users of the system and to enhance general understanding of terms used.
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