Monday, June 26, 2023

Placebo Effect versus Nocebo Effect

›
In placebo-controlled clinical trials, a placebo refers to an inactive or inert substance or treatment that has no specific therapeutic effe...
Wednesday, June 21, 2023

SAE reporting - from non-serious AE to serious AE - one event or two events?

›
An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious (therefore se...
1 comment:
Saturday, June 17, 2023

Regulatory Education for Industry (REdI) Annual Conference 2023 - Slides and Recordings

›
Early this month, FDA conducted 'Regulatory Education for Industry (REdl) Annual Conference 2023'. This annual conference provided ...
Friday, June 02, 2023

Resubmission of NDA/BLA After CRL: Class 1 versus Class 2 resubmission

›
If new drug application (NDA) or biological license application (BLA) is not approved by the FDA, the sponsor will receive a complete respon...
Monday, May 29, 2023

Final FDA Guidance "Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products" - what we learned?

›
In May 2023, FDA published the final guidance for industry " Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biolo...
1 comment:
Sunday, May 21, 2023

Comparing assumptions for sample size estimation with the interim and final results

›
Sample size estimation is one of the critical aspects of the clinical trial design. The sample size estimation is usually based on the prima...
1 comment:
Wednesday, May 17, 2023

Another successful trial with randomized withdrawal design

›
Biotech company PTC Therapeutics announced today that their phase III study of Sepiapterin in PKU patients achieved the primary efficacy en...