Module 3 2019

Recommended references

ICH Q6A: https://database.ich.org/sites/default/files/Q6A_Guideline.pdf

ICH Q6B: https://database.ich.org/sites/default/files/Q6B_Guideline.pdf

ICH Q3A(R2): https://database.ich.org/sites/default/files/Q3A_R2__Guideline.pdf

ICH Q3B(R2): https://database.ich.org/sites/default/files/Q3B_R2__Guideline.pdf

ICH Q3C(R6): https://database.ich.org/sites/default/files/Q3C-R6_Guideline_ErrorCorrection_2019_0410_0.pdf

ICH Q3D(R1): https://database.ich.org/sites/default/files/Q3D-R1EWG_Document_Step4_Guideline_2019_0322.pdf

ICH Q8(R2): https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf

ICH Q9: https://database.ich.org/sites/default/files/Q9_Guideline.pdf

ICH Q10: https://database.ich.org/sites/default/files/Q10_Guideline.pdf

ICH Q11: http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html

ICH Q12: https://database.ich.org/sites/default/files/Q11_Guideline.pdf

Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System: http://www.fda.gov/cder/guidance/3618fnl.pdf

EMA Guideline on Real Time Release Testing (Formerly Guideline on Parametric Release): https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-real-time-release-testing-formerly-guideline- parametric-release-revision-1_en.pdf

The Organisation for Professionals in Regulatory Affairs