ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines Step 2b
Retrieved on:
Dimanche, juin 2, 2024
Consensus, Sentinel, Real-World Evidence, NPV, Privacy, Smoking, Business analyst, Interest, Scope, Section 3, Missing data, Attention deficit hyperactivity disorder, World Health Organization, Thrombosis, Vaccination, Artificial intelligence, GVP, Element, ICD-10, ICD, Target, Clutch (eggs), MedDRA, Anaphylaxis, Data collection, Multi, Registry, Infant, International Society, Collection, Incidence, Clinical study design, FD, Replication (computing), Deference, Failure, CDM, Innovation Center station, Prevalence, Diagnosis, Mortality, Pregnancy, Person, Data analysis, Classification, Committee, Knowledge, Silver, PMID, Development, Roger Hawkins (drummer), Record, Len Bias, 1113, Polypharmacy, Sensitivity analysis, Protocol, Risk, European Medicines Agency, FDA, Real, Joint, Step, Quality control, Documentation, Standard of care, Health care, Accident, Checklist, Database, Birth weight, Statistics, Communication, Natural language processing, Table, Data Governance Act, Common data model, Study, Reproduction, Quality assurance, European, BMJ, Quality, Conducting, Comorbidity, NMPA, Knowledge Organization (journal), Drug development, DHT, Conceptual, ISPE, Adrenaline, Marketing, Cancer, EHR, Phenotype, Safety, Rehabilitation, Research design, HCPCS, Treatment, Allergy, Electronic health record, Validity, Death, MAH, Quality of life, 1128, Confidentiality, Selection bias, Prescription, Machine learning, Duration, CIOMS, Vaccine, ICMJE, Injury, Workplace, Section 5, National Cancer Institute, Bangladesh Technical Education Board, Interval (mathematics), Regulation, Data quality, Management, GCP, Digital, Software, Meta-analysis, SNOMED, Section 8, Use, Biology, QC, Uncertainty, Birth defect, PPV, FDN, Publication bias, Draft, Shareware, Frailty, Disulfiram-like drug, Guideline, Publishing, Gestational diabetes, De novo, Big data, Conduct, Medication, Bias, Immunodeficiency, EMA, Social media, International Classification of Diseases, History, Name, Data management, M10, Algorithm, Ageing, Natural history, SAP, Asian literature, Disability, QA/QC, Immortal, NDC, Book, Human voice, Central Statistics Office (India), Content, Birth, Frontiers Media, Metadata, RxNorm, Data governance, GPP, Structuring, Radiology, Benzodiazepine, Lash, User experience, Theft, Methodology, Objective, RWD, COMMUNICATION, DATA, Literature, Health information management, Clinical trial, Dependent and independent variables, Research, Patient, ATC, INTRODUCTION, TB, Section 13, Contraindication, Insurance, Concomitant, Data, Index, M14, Gestational age, Data curation, Biomarker, ICH, Paper, CHMP, Medical device
Key Points: