Reference books/resources for validation and stability

[vliu]

I realised there is a seperate section for resources but I thought by posting here I would get a faster and more response. Apology for that.

I am in the search of good reference books/sites for validation (level 1 -3) and stability studies, from feasability to registration stability (i.e. hints and tips and what are the critical parameters). I realised there is a couple mentioned in the resource section but does anyone else know any other good reference books that they would recommand?

Thank you in advance.

[LC_labrat]

For pharmaceuticals I recommend using the ICH guidelines, covers validations and stability studies.

[vliu]

Thank you for the reply LC_labrat. Indeed, there is alot of useful information in the ICH website

[MTS]

I'm sorry to use this part of the forum to promote my own book but I think that you may find it very helpful. The title is 'Validation of Analytical Methods for Pharmaceutical Analysis'. It is a guide to interpreting the ICH guidelines on method validation and provides useful advice on experimental procedures and typical acceptance criteria to use for the validation characteristics required for different types of methods. The book received a very positive review in the RSC magazine, 'Chemistry World' earlier this year. There is a preview on the website (http://www.mournetrainingservices.co.uk ... ation.html) so that you can get a feel for the content. A useful practical guide at less than £30.
Apologies again for promoting myself but it seemed appropriate for this thread.