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Frequent ly Asked Q uestions d Recommendation o f ...

1234567 Q4B: EvaThe Q4B Ex1. What is PD2. What is Q4B3. Why is Q4B4. How does in5. How do regu6. When can Q7. Can harmonInternational Conaluation anxpert Working GG? ..B? ..B necessary? ..ndustry use theulators use the Q4B Annexes benised pharmaconference on HarmoICH SecretariatTend RecommGroup Q4B Annexes? Q4B Annexes?e used? ..opoeial text be conisation of Technt, Chemin Louis-Dunelephone: +41 (22) 3admin@Frequentmendation od a set of frequeerstand the use ..considered inter nical Requirements nant 15, Box 1338 32 06, http://www tly Asked Q of Pharmac ently Asked que and implication ent Date: 26 Apable of Conte.

ICH Q4B Frequently Asked Questions Document Document Date : 26 April 2012 3 3. Why is Q4B necessary? One of the ultimate goals for the pharmaceutical industry is the ability to generate analytical data by a single test method which is

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