Wednesday, July 17, 2013

Periodic Safety Report: DSUR, PSUR, PBRER, ASR, IB, Orphan Designation Annual Report

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During the drug development and after the drug is on the market, the sponsor or market authorization holder has obligations to submit the sa...
9 comments:
Friday, July 12, 2013

SOP, WP, MAPP, SOPP for FDA Internal Staff / Reviewers

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In an earlier discussion, I compared the differences between SOPs (Standard Operation Procedures) and WPs (Working Procedures). Pharmaceut...
Wednesday, July 03, 2013

Clinical Trial Regulations in European Union (EU) Countries

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For clinical trials in European Union countries, the regulations are mainly based on:   European Union (EU) clinical-trial legislation (...
3 comments:
Sunday, June 23, 2013

Serious Adverse Event (SAE) Data Collection / Reporting Using Electronic Data Capture (EDC) System

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Clinical trials require ongoing and continuous monitoring of the safety for study participants. According to 21 CFR 312.64 , Investigators ...

One-Sided Test in A Superiority Trial

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In this year’s ATS meeting, the results for a study “ Zemaira in Subjects With Emphysema Due to  Alpha1-Proteinase Inhibitor  (API) Defici...
2 comments:
Sunday, June 16, 2013

Drug for Treating Rare Diseases: Orphan Drug, Orphan Disease, Orphan Subset

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Section 526(a) of the Federal Food, Drug and Cosmetic Act (FD&C Act) defines a ‘‘rare disease or condition’’ as following: any dis...
1 comment:
Monday, May 27, 2013

The Size of Safety Database In Drug Development Program

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In planning the clinical program for drug approval, in addition to the efficacy assessment, the adequate size of the safety database is usu...
4 comments: