Thursday, December 26, 2013

Quantification of Risk – Breaking down adverse reaction into common and uncommon categories

›
When we conduct a clinical trial using an approved product, we may run into the requests for the list of common, very common adverse events...
Tuesday, December 10, 2013

Pharmacokinetic studies when endogenous compounds exist and pre-dose concentrations are not zero

›
This Monday, FDA issued a new guidance titled “ Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA ”. ...
9 comments:
Sunday, December 08, 2013

SAS Programming for PK Time-Concentration Curve Using SGPLOT

›
Comparing with other software/tools for generating the graphs, SAS/Graph may be inferior. Programming to generate graphs using SAS/Graph la...
2 comments:
Sunday, November 17, 2013

Causality Assessment, Causality Categories for Reporting Adverse Events or Adverse Reactions

›
In clinical trials, safety reporting is a critical issue. This includes the reporting of safety information (adverse events or adverse reac...
Monday, November 11, 2013

Submit the Clinical Trial Datasets to FDA: Using the right .xpt file format

›
When we submit the clinical trial datasets to FDA, we need to convert the datasets in original format (.sas7bdat) to .xpt format. There are ...
6 comments:
Saturday, November 02, 2013

Placebo Mean Imputation (PMI)

›
A while ago, I discussed several simple imputation methods in LOCF, BOCF, WOCF, and MVTF . Recently, I noticed another simple imputation me...
Friday, October 25, 2013

Replies to Inquiries to FDA on Good Clinical Practice

›
Good Clinical Practice (GCP) is the law of conducting the clinical trials. Sometimes, interpreting the law is challenging, the same is true...
2 comments:
Monday, October 21, 2013

Monitoring the double-blind study: unblinded pharmacist, unblinded monitor, and drug kit

›
In many clinical trials with biological products, the investigational products usually need to be reconstituted before the use. If the stud...