List of Abbreviations

Abbreviations Meaning More than one meaning AAALAC Association for Assessment and Accreditation of Laboratory Animal Care ACE Angiotensin-converting enzyme ADH Autosomal dominant hypercholesterolaemia ADME Absorption, distribution, metabolism and excretion ADMET Absorption, distribution, metabolism, excretion, toxicity AEMPS Spanish Agency for Drugs and Medical Products AI Artificial intelligence AIDS Acquired immunodeficiency syndrome AIFA Italian Medicines Agency AIS Arztinformationssystem AMNOG Arzneimittelmarkt Neuordnungsgesetz AMPA a-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (receptor) AP Angina pectoris API Active pharmaceutical ingredient AR Assessment report ASMF Active substance master file ASMR Amélioration du Service Médical Rendu ATC Anatomical therapeutic chemical ATMP Advanced therapy medicinal product ATP Adenosine triphosphate AUC Area under the curve BA Bioavailability BBB Blood-brain barrier BCS Biopharmaceutical classification system BEST Biomarker, endpoints and other tools BLA Biologics license application BMP Bone morphogenetic protein BNP Brain natriuretic peptide BPCA Best Pharmaceuticals for Children Act BQP Biomarker qualification program BSE Bovine spongiform encephalopathy CA Competent authority CAP College of American Pathologists CAPA Corrective and preventive action CAR-T Chimeric antigen receptor T-cell (therapy) CAS Chemical abstract service (registration number) CAT Committee for advanced therapies CBA Cost-benefit analysis CBER Center for Biologics Evaluation and Research CD4 Cluster of differentiation 4 (cell) CDA Confidentiality agreement CDER Center for Drug Evaluation and Research CDP Clinical development plan CDRH Center for Devices and Radiological Health CE Conformité Européenne CEA Cost-effectiveness analysis CED Coverage with evidence development CEO Chief executive officer CEREP Inhibitory activity and selectivity of compounds on the PDE superfamily CETP Cholesteryl-ester-transfer-protein cGMP Cyclic guanosine monophosphate CJD Creutzfeldt-Jakob disease CKD-EPI Chronic kidney disease epidemiology collaboration equation CKL Clearance CLIA Clinical Laboratory Improvement Act clogP Partition coefficient between n-octanol and water CMA Critical material attributes or cost-minimization analysis CMC Chemistry, manufacturing, and control CNS Central nervous system COGs Cost of goods COMP Committee for orphan medicinal products CP Centralized procedure CPP Critical process parameters CQA Critical quality attributes CRO Contract research organization CRP C-reactive protein CSE Cystathionine-?-lyase CSP Clinical study protocol CT Computed tomography CTA Clinical trial application CTD Common technical document CUA Cost-utility analysis CYP Cytochrome P450 CyTOF Cytometry by time-of-flight DCDS Development core data sheet DD Due diligence DDI Drug-drug interaction DDP Drug development pathway or design and development plan 1 DEL DNA-encoded chemical libraries DLTs Dose-limiting toxicities DMC Data monitoring board DMF Drug master file DMSO Dimethyl sulphoxide DNA Deoxyribonucleic acid DoH Declaration of Helsinki DP Drug product or decentralized procedure 1 DRF Dose-range finding DSMB Data safety monitoring board EAC Endpoint adjudication committee EAP Early access program EC Ethics committee ECG Electrocardiogram ECHA European Chemical Agency ED Exectile dysfunction ED50 50% of the test objects show the expected effect EDMF European drug master file EFD Embryofetal development EGF Epidermal growth factor ELISA Enzyme-linked immunosorbent assay EMA European Medicines Agency EoP End-of-phase EPC European Patent Convention EPO European Patent Office EQA External quality assurance ERA Environmental risk assessment ERK Extracellular signal-regulated kinase ERP External reference...