Scientific Guidelines

1. Implementation strategy of ICH Guideline M12 on drug interaction studies

   Implementation strategy of ICH Guideline M12 on drug interaction studies

2. Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance

   Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance

3. Methylphenidate, prolonged-release tablet 18 mg, 27 mg, 36 mg and 54 mg and modified release capsule 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg product-specific bioequivalence guidance

   Methylphenidate, prolonged-release tablet 18 mg, 27 mg, 36 mg and 54 mg and modified release capsule 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg product-specific bioequivalence guidance

4. Draft reflection paper on the use of information in European Union herbal monographs and assessment reports for borderline issues

   Draft reflection paper on the use of information in European Union herbal monographs and assessment reports for borderline issues

5. Paclitaxel (nanoparticle albumin-bound) powder for suspension for infusion, 5mg/ml

   Paclitaxel (nanoparticle albumin-bound) powder for suspension for infusion, 5mg/ml