Chromatography Forum

hi people!! i wnat to know how much time is considered "normal" in order to develop an analysis method for a product withg 3 or 4 drugs for example. Ans how much time for its validation.
Thanks in advance!

hi people!! i wnat to know how much time is considered "normal" in order to develop an analysis method for a product withg 3 or 4 drugs for example.

If you're lucky and smart (in that order), one day. If you're unlucky, anything up to several weeks. (I'm assuming that you're talking about potency or content uniformity here. If it's purity or stability-indicating, it can take much longer).

Ans how much time for its validation.

If you need to establish ruggedness (different labs, different days), and there is no competition for the participants' time, probably a couple of weeks.

thanks a lot Tom for your prompt reply...by the way, and just for curiosity, and of course if you know, how much cost (in money) to develop a method for a product with 3 or more drugs?
thanks again!

Developing the method can run very quickly, depending on the chemical moeities present, but verification takes some time. I remember running a 4 component mixture and getting it right on the 1st run, only to discover that extraction accuracy was a concern (took maybe an hour to come up with proper extraction). It's more typical, depending on the application, to run 1-3 months of verification/development including some forced deg work on the initial end and robustness as the last step. I'd say industry standard for validations is 3 weeks, but multicomponent mixtures can run longer (you'll have 3xrange experiments at least). If you're talking Q&D, you can do a verification in a day (range only...) but not validation. Solution stability is usually the rate limiter for reduced validations.

Slammy1 is right. It depends on how "lucky" you are in terms of problems. My rule of thumb (only half in jest) is take your most pessimistic estimate regarding time, double it, and move to the next higher unit of measure.

Thus, if you think it can be done in two days, allow four weeks.

The actual cost, of course, will then depend on what your particular salary and expense structure.

Our QA department just gave us (Monday) that we had one week to re-validate a test procedure originally validated two years ago, because that validation wasn't performed on a "qualified" HPLC system, even though all parameters for validation including linearity, reproducibility, recovery, etc., were exceptional. But of course the formula has changed over that time period anyway. So that's this week's crisis. And they supplied a wrong placebo, further wasting our time. Oh, yes, I told them that they'd need to assay the raw materials before starting production Monday, and lots of those documents haven't been written yet, and one test procedure for a raw material needed to be written, and all approved. So I'm (again) the bad guy for exposing their lack of planning and communication.....

Ahh the infamous "how long is a peice of string question"

When I was in contract pharma... we'd charge 'em $500/hr for method development and a flat rate for validation (depending on class and complexity required). At that time we were doing a lot of novel work like proteomics and low level surfactant analysis, so even at that we were getting a lot of customers. I'm guessing this is for a formulating pharmacy? Generally, they aren't so particular in how much effort you put into validation (more a method verification than an ICH category I 3-component validation). If you're looking at pricing, I'd quote out an hourly rate until you get the hang of things. The 3-week quote depends on a lot of things, as CPG has indicated, also familiarity with the method (assumes you've run the key parameters before proceding to validation) and having a system in place to run through the validations. The first report is always the hardest, you know, but once templates and systems are in place the 3-week quote applies in my experience.