Electronic SignatureAn electronic signature is a compilation of any kind of signature (symbols) executed, adopted, or approved by an individual to be the legally binding equivalent of his/her handwritten signature. Signatures,Electronic signatures,documents,digital...
Agatha Archives
Electronic Patient Reported Outcome (ePRO)
Electronic Patient Reported Outcome (ePRO)Collect patient reported outcome (PROs) using electronic means, for example through apps, wearables, websites, etc. Patients,patient-reported outcomes,study,symptoms,platform,electronic patient-reported...
Electronic Data Capture (EDC)
Electronic Data Capture (EDC)A system capturing patient case report form information. Time,trial,clinical trials,forms,studies,integration,Electronic Data Capture,process,features,query,electronic case report forms. Application,regulatory compliance,contract research...
Electronic Application Form (eAF)
Electronic Application Form (eAF)A PDF fillable form will be provided for each MAA and variation, which will be removed from the EMA human and vet MAA and variations. Form,electronic application forms,submissions,competent...
Drug Product (DP)
Drug Product (DP)A finished dosage formulation containing a drug substance (e.g., tablets, capsules, solutions) Drug,processes,development,control,drug product,drug substance,condition,disease. Drug Product (DP,issues,study,submission,devices,Primary...
Drug Master File (DMF)
Drug Master File (DMF)A DMF is a type of "API" or "Application Programming Interface". An API is a collection of functions used to access functionality provided by another program. For example, an API might allow one application to call into another application to...
Double Blind Research Design
Double Blind Research DesignA blind study where neither the participants nor researchers know who is in the group receiving the intervention and who is not. Studies,treatments,outcomes,analysis,type,Exclusion criteria,analyses,disorder,size,Study design,study...
Dose-Ranging Study
Dose Ranging StudyA study in which different doses of an experimental treatment are compared to see which one has the greatest effect and causes the fewest side effects. Phase,treatment,studies,trial,drugs,disease,clinical trials,Dose-Ranging Study,participant,study...
Dosage Strength
Dosage Strength(1) The ratio of the active ingredients to inactive ingredients in a pharmaceutical preparation. (2) The quantity of active ingredients per unit dose of a medication. Dose,drug,patients,effects,risk,level,medicine,dosage,adverse events,healthcare...
Dosage Form
Dosage FormA frequently used medication is one that is stored in its original container (e.g., a bottle) and then taken from the container when needed. Forms,drug,doses,review,medication,study,solid dosage forms,oral dosage forms,drug product,drug substances,Pharm...