Saturday, November 21, 2015

Pediatric Study Plan (PSP) and Paediatric Investigation Plan (PIP)

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Pharmaceutical companies usually put their efforts into the adult population when they develop a new compound. There is usually  low rates o...
Monday, November 09, 2015

Human Genetic Enginering, DNA Modifications, DNA Editing, Genome Editing, Trans-humanism, Transgenic, xenotransplantation, Humanized Animals, and Human Chimeras

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Last week, NPR had a report "Should Human Stem Cells Be Used To Make Partly Human Chimeras?". Apparently, there was a meeting in N...

Minimizing the missing data: data collection after subjects withdraw from the clinical trial

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Recently, I have heard quite some discussions about the data collection in clinical trials for subjects who discontinue early from a clinic...
Tuesday, November 03, 2015

FDA Issued Draft Guidance for Industry for HIV drug "Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment"

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In an effort to help the industry to understand the requirements and expectations for drug development, FDA started to issue the guidance on...
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Monday, October 12, 2015

Sample Size Estimation Based on Precision for Survey and Clinical Studies such as Immunogenicity Studies

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Sometimes, we may need to calculate the sample size to estimate a population proportion or a population mean with a precision or margin of ...
Saturday, October 03, 2015

How Low in Sample Size Can We Go? FDA approves ultra-orphan drug on a 4-patient trial

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The development of the orphan drugs has been red hot in recent years due to the favorable regulatory environment and the government incentiv...
Tuesday, September 15, 2015

Time to Event End Points

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Time to Event analysis has expanded beyond the traditional term of survival analysis even though the term of survival analysis may still be...