Pharmacist Nama

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50 key terminologies used in regulatory affairs | Follow Brindha Chandrasekaran 1. Investigational New Drug (IND)   2. New Drug Application (NDA)   3. Clinical Trial Application (CTA)   4. Institutional Review Board (IRB)   5. Good Clinical Practice (GCP)   6. Informed Consent   7. Protocol   8. Sponsor   9. Adverse Event (AE)   10. Serious Adverse Event (SAE)   11. Regulatory Authority   12. Case Report Form (CRF)   13. Data Monitoring Committee (DMC)   14. Marketing Authorization Application (MAA)   15. Post-marketing Surveillance   16. Pharmacovigilance   17. Bioavailability   18. Biological License Application (BLA)   19. Good Manufacturing Practice (GMP)   20. Abbreviated New Drug Application (ANDA)   21. Fast Track Designation   22. Orphan Drug Designation   23. Breakthrough Therapy Designation   24. Risk Evaluation and Mitigation Strategy (REMS)   25. Qualified Person (QP)   26. Common Technical Document (CTD)   27. ICH Guidelines   28. Clinical Hold   29. Protocol Deviation   30. Expedited Review   31. Placebo   32. EudraCT   33. Electronic Common Technical Document (eCTD)   34. Investigator’s Brochure (IB)   35. Substantial Amendment   36. Declaration of Helsinki   37. Blinding (or Masking)   38. Randomization   39. Endpoint   40. Health Technology Assessment (HTA)   41. Safety Monitoring Plan (SMP)   42. Clinical Significance   43. Non-Inferiority Trial   44. Comparator   45. Directive 2001/20/EC   46. Site Initiation Visit (SIV)   47. CRO (Contract Research Organization)   48. Quality Assurance (QA)   49. Study Coordinator   50. Safety Reporting

50 Clinical Trial Terminologies - PART-2 | Follow Brindha Chandrasekaran 1️⃣ Blinded adjudication 2️⃣ Subgroup analysis 3️⃣ Non-inferiority trial 4️⃣ Superiority trial 5️⃣ Equivalence trial 6️⃣ Multicenter trial 7️⃣ Registry study 8️⃣ Post-marketing surveillance 9️⃣ Placebo-controlled trial 🔟 Active-controlled trial 1️⃣1️⃣ Withdrawal design 1️⃣2️⃣ Run-in period 1️⃣3️⃣ Endpoint determination 1️⃣4️⃣ Composite endpoint 1️⃣5️⃣ Surrogate endpoint 1️⃣6️⃣ Risk-benefit analysis 1️⃣7️⃣ Allocation concealment 1️⃣8️⃣ Randomization sequence 1️⃣9️⃣ Cluster randomization 2️⃣0️⃣ Stratified randomization 2️⃣1️⃣ Block randomization 2️⃣2️⃣ Dynamic randomization 2️⃣3️⃣ Event-driven trial 2️⃣4️⃣ Time-to-event analysis 2️⃣5️⃣ Kaplan-Meier curve 2️⃣6️⃣ Hazard ratio 2️⃣7️⃣ Cox proportional hazards model 2️⃣8️⃣ Dose-ranging study 2️⃣9️⃣ Dose-escalation study 3️⃣0️⃣ Maximum tolerated dose (MTD) 3️⃣1️⃣ Median effective dose (ED50) 3️⃣2️⃣ Therapeutic index 3️⃣3️⃣ On-treatment analysis 3️⃣4️⃣ Exploratory endpoint 3️⃣5️⃣ Pre-specified analysis 3️⃣6️⃣ Post hoc analysis 3️⃣7️⃣ Sensitivity analysis 3️⃣8️⃣ Generalizability 3️⃣9️⃣ External validity 4️⃣0️⃣ Internal validity 4️⃣1️⃣ Interim endpoint 4️⃣2️⃣ Early stopping 4️⃣3️⃣ Withdrawal rate 4️⃣4️⃣ Lost to follow-up 4️⃣5️⃣ Attrition bias 4️⃣6️⃣ Selection bias 4️⃣7️⃣ Observer bias 4️⃣8️⃣ Detection bias 4️⃣9️⃣ Performance bias 5️⃣0️⃣ Reporting bias Link for Part-1 : https://lnkd.in/gGdNMAid

#Antibiotics do not treat viral infections such as colds and flu 🤧. Always seek advice from a qualified healthcare professional before taking antibiotics.

#Antibiotics do not treat viral infections such as colds and flu 🤧. Always seek advice from a qualified healthcare professional before taking antibiotics.