Bioequivalence and Bioavailability Forum

Dear HS,
Thank you very much for your quick help. I feel very lucky to find out this forum bcoz I found many valuable answers to my problems (many, many problems and do not know whom to ask).

❝ If you want to deal with studies keeping a global perspective in mind, you must be able to evaluate at least the following type of studies / apply the following statistical methods:

Thank you for your advice! At the moment we are doing only simple study, 2x2 single-dose, crossover design for domestic companies. However, we are planning to do more complicated study (we have received several orders from sponsors to do study for modified-release products with both single and multiple-dose)

❝ If you want to write software for all these methods starting from scratch, this would be a rather tough and time-consuming job (- I wouldn't recommend it except to masochists).

I never thought I will write any software in my life, especially statistical one. I am not good at computer and always struggle with statistic (however, I am really interested in statistics for BE).

❝ Consider going with one of the general-purpose PK/PD/BE-software packages instead despite they are expensive, the support is slow, etc...

❝ The industrial standard is WinNonlin, a little bit cheaper is Kinetica (at the priece of a somehow weird user interface).

My center is a governmental one so it is not easy to buy something. We have asked for buying a software many times but not be approved. Actually, it is our fault as my personal thought: we are using Excel to do statistic and keep giving the results of bioequivalence to sponsor ( secret pls, I won't tell you where I am from) so everything seems OK and why have to buy a software, use Excel! Now, when foreign company from developed countries come and ask us to do study for them and the harmonization between countries force us to change. Actually, I think the way we are using Excel at the moment may be accepted bcoz we are at starting steps,there is no regulations for BA/BE study yet in my country. However, it won't be accepted in the future, definitely! We are not calculating anything mentioned in a real BE study: no geometric mean, no LS means, no inter, intra-subject variability, no power of the study...We do not know how to solve our situation at the moment: no software, no proper training (our center is at the highest level in my country, so can not change experience with other centers, going oversea is too luxury for us), no books (All the books in the lists you have recommended not easy to be found in my city bcoz they are expensive and not many people work in this field so those books are not available), no access to the good database (such as Science Direct or Wiley InterScience); luckily the Internet speed is faster recently. You may feel funny but it is the fact of a developing country. (Sorry if I bother you too much with long story, just want you to be in sympathy if I have any too simple questions later)

❝ I'm too short in time to give you the entire procedure - vacation approaching

Terribly sorry for occupying your time again. Wishing you a great vacation! However, please spend some time to answer my and others' questions - we are really waiting for your help! (I am really impressive with huge works done by you in this forum with the answers to almost all questions) I will read carefully all the posts and documents you suggested and definitely, I will come up with plenty questions which need your help!

❝ 2. Your English is better than some I've read from 'native' speakers...

Hope that you did not regret to tell me as above. You gave me confidence so I am writing "a thesis" to reply you . Thank you very much for your compliment!
Best regards,
HTMN.