15.1 Adopted European guidelines for biopharmaceutic studies

The guidance is to be applied in addition to the following European Union guidelines that have been adopted by the TGA, some with annotations:

• Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev 1/Corr**), adopted with annotation.
• Guideline on quality of oral modified release products (EMA/CHMP/QWP/428693/2013)
• Guideline on the quality of transdermal patches (EMA/CHMP/QWP/608924/2014)
• Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CHMP/EWP/280/96), adopted with annotation
• Guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins (CHMP/EWP/89249/2004).
• Questions and answers: positions on specific questions addressed to the Pharmacokinetics Working Party (EMA/618604/2008).