Bioequivalence and Bioavailability Forum

Dear Venu,

excuse me for cutting in.

❝ Regarding the sentence "I doubt that any regulatory agency will say you need a Master's degree in Stats." I will suggest you to read all the guidelines thoroughly.

❝ You can also search in the Google on this topic and you will get many articles and information on this.

OK, let’s go to the bottom line. Which guidelines are you referring to? Which keywords in Google did give you ‘many articles and information on this’?

I’m not qualified in your sense either, because I’ve got no master’s degree in statistics myself (though I’m a member of the International Biometric Society, the International Society for Clinical Biostatistics, and the European Network for Business and Industrial Statistics).

Just to give you some examples:

• First programming experience in 1976, coding a software package for PK/NCA/BE (60,000+ lines of source code in 1981 – 1983), evaluation of 500+ PK/BA/BE-studies, international lecturer on BE, co-author of a textbook on BE, never getting a deficiency letter questioning my qualifications,…
  

  not qualified (that’s me)

  
  
• Unplanned interim analyses (if planned, without α]-adjustment), improper handling of missing values, violating statistical assumptions (ANOVA of values from a discrete distribution like t_max), violation of statistical analysis plans (if existing at all), 1000 pages of SAS-output in a BE-study including an ANOVA-breakdown for eye-color (OK, the drug was atropine ), ignoring multiplicity issues,…
  

  qualified (PhD in mathematical statistics)

Unfortunately I’ve seen far too many ‘qualified’ Push-the-Button-Statisticians in the last years, and I’m always happy if someone goes beyond (you would probably say below) SAS, like in this post.

Since the European Concept Paper on BA/BE for HVDs/HVDPs is open for comments from ‘International scientific societies in statistics and in pharmacokinetics’ only, I tried to interest my colleagues of the IBS to no avail. They considered the topic ‘trivial’; their lowest entry point most likely is the Kullback-Leibler divergence…

So please reconsider your prejudices! Three years of SAS programming experience do not impress me at all.