651 results
Categories
Human Remove Human filter
-
List item
ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk (updated)
Last updated: 03/07/2020 -
List item
Lapatinib product-specific bioequivalence guidance (updated)
Last updated: 03/07/2020 -
List item
Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation (updated)
Last updated: 01/07/2020 -
List item
Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials (updated)
Last updated: 29/06/2020 -
List item
Abiraterone product-specific bioequivalence guidance (updated)
Last updated: 15/06/2020 -
List item
Clinical pharmacology and pharmacokinetics: questions and answers
Last updated: 05/06/2020 -
List item
Dasatinib product-specific bioequivalence guidance
Last updated: 06/05/2020 -
List item
ICH Q3C (R6) Residual solvents
Last updated: 04/05/2020 -
List item
ICH E8 General considerations for clinical studies
Last updated: 07/04/2020 -
List item
Etonogestrel and ethinylestradiol vaginal delivery system product-specific bioequivalence
Last updated: 01/04/2020 -
List item
Biostatistics
Last updated: 25/03/2020 -
List item
ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management
Last updated: 04/03/2020 -
List item
ICH S5 (R3) guideline on reproductive toxicology: Detection of toxicity to reproduction for human pharmaceuticals - step 5
Last updated: 18/02/2020 -
List item
ICH E9 statistical principles for clinical trials
Last updated: 18/02/2020 -
List item
Quality of medicines questions and answers: Part 1
Last updated: 05/02/2020 -
List item
Alectinib product-specific bioequivalence guidance
Last updated: 19/12/2019 -
List item
Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
Last updated: 22/11/2019 -
List item
Clinical investigation of medicinal products for the treatment of gout
Last updated: 14/11/2019 -
List item
ICH guideline E19 on optimisation of safety data collection - Step 2b
Last updated: 30/10/2019 -
List item
ICH M10 on bioanalytical method validation
Last updated: 30/10/2019 -
List item
Pharmacokinetic and clinical evaluation of modified-release dosage forms
Last updated: 29/10/2019 -
List item
Gefitinib product-specific bioequivalence guidance
Last updated: 15/10/2019 -
List item
Cabozantinib product-specific bioequivalence guidance
Last updated: 15/10/2019 -
List item
Colchicine product-specific bioequivalence guidance
Last updated: 15/10/2019 -
List item
Ezetimibe product-specific bioequivalence guidance
Last updated: 15/10/2019