Bioequivalence and Bioavailability Forum

Regulatory Query for study repeat [Study As­sess­ment]

posted by luvblooms  – India, 2013-07-30 10:28 (4304 d 09:50 ago) – Posting: # 11122
Views: 20,234

Dear Sam,

A few more thngs to look at from formulation point of view

❝ ❝ 2. Was there a change in the formulation or process? From pilot batch to scale-up batch...

❝ There was no change in the formulation or process.

Well, how about

1. the changes in API particle size? Was the PSD range too wide and both the lots (pilot and pivotal). Normally particle size changes doesnt give major difference in FED condition as drug stays in stomach for longer time and have sufficient fat to get solubilized but these changes are prominent in Fasting condition.
   
2. Different form of API?: were the form (polymorphic/amorphous) remains same from pilot to pivotal?
   
3. Different lot of API?Again to the first point are there any change in lots of API?
   
4. Changes in Inactive ingredient grade or quality? Was there any change in amount or grade of any inactive ingerdient that may affect the release from the product. Some very commomly used excipients behave wildly within different grades.

❝ ❝ 3. Have you checked the PK data in details, both pilot and pivotal.

❝ I have checked the Pilot and Pivotal data thoroughly.

Any differences observed in Tmax or shape of C-t curve? That could give you an idea why the product behave was different.

❝ ❝ 4. Any difference in study population between studies?

❝ The study populations are totally different. Pilot are carried out in other CRO and Pivotal in other

How about the meal compositions? Were they remain the same? In India the food varies a lot between Chennai and Ahmedabad and so thus the performance of the formulations (this is based on my experience of some IR and XR products). Get a hold of that too along with the demographic data. Even that might give you some idea.


Hope this will help..

Complete thread:

• Regulatory Query for study repeat sam 2013-07-27 07:50 
  • Repeats ElMaestro 2013-07-27 11:01
    • Repeats sam 2013-07-27 11:18
      • Repeats ElMaestro 2013-07-27 11:31
        • Repeats sam 2013-07-27 11:57
          • Repeats ElMaestro 2013-07-27 12:27
            • Repeats sam 2013-07-27 12:45
          • Bad science Helmut 2013-07-27 14:15
            • Bad science sam 2013-07-28 09:05
              • Posting style & incomplete information Helmut 2013-07-28 12:32
                • Posting style & incomplete information sam 2013-07-29 06:46
                  • RTFM! Helmut 2013-07-29 07:53
                    • RTFM! sam 2013-07-29 08:40
                      • copy & paste error or what? Helmut 2013-07-29 11:14
                        • copy & paste error or what? sam 2013-07-29 12:46
                    • Calm down! jag009 2013-07-29 16:06
                  • Slightly off-topic: The wonders of pilot trials ElMaestro 2013-07-29 09:19
                    • Futility rule? Helmut 2013-07-29 12:16
                      • Futility rule? ElMaestro 2013-07-29 12:46
                    • Slightly off-topic: The wonders of pilot trials sam 2013-07-29 12:41
                      • PE of AUC? Helmut 2013-07-29 12:45
                        • PE of AUC? sam 2013-07-29 12:56
                          • EOD Helmut 2013-07-29 13:18
                  • Posting style & incomplete information jag009 2013-07-29 16:32
                    • Posting style & incomplete information sam 2013-07-30 06:08
              • Bad science ElMaestro 2013-07-28 12:43
        • Repeats jag009 2013-07-27 22:17
          • Repeats ElMaestro 2013-07-27 23:11
  • Regulatory Query for study repeat jag009 2013-07-27 22:29
    • Regulatory Query for study repeat sam 2013-07-29 12:36
      • Regulatory Query for study repeatluvblooms 2013-07-30 08:28
        • More questions.. jag009 2013-07-30 16:53