FDA (ICH) Guidance: M12 Drug Interaction Studies & Questions and Answers
ICH Guidance: M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
ICH M14 Guideline: General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
ICH (Final) Guidance: Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development
USFDA Guidance: ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities
USFDA/ICH - E6(R3) GCP Guideline: Modernizing the Design & Conduct of Clinical Trials
ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management
ICH/ USFDA Guidance: S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
ICH-Quality Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products
ICH (USFDA) Guidance: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
ICH M11 Guidance: Tech Spec - Clinical Electronic Structured Harmonised Protocol (CESHARP)
ICH Guidance: Q3D(R2) ELEMENTAL IMPURITIES
ICH Guidances: Q2(R2) Validation of Analytical Procedures, Q14, M12, E11A, E14 & S7B Updation
ICH - Q9(R1) Quality Risk Management Draft Guidance Uupdation
ICH-Draft Guideline on Pediatric Extrapolation & FInal Guidance on Considerations for Clinical Study
ICH's updated Draft Guidelines on Analytical Method Development
ICH guideline Recommendation on Daily (PDE) Limits for Seven Mutagenic Impurities
ICH Q13 Draft Guideline reaches Step 2 of the ICH process