International scientific guideline: Questions and answers on the withdrawal of the 'Guideline on pharmacokinetics and metabolic studies in the safety evaluation of new medicinal products in animals (3BS11A)'

About this guideline

Overseas effective date: 15 Sep 2014

Categories: Nonclinical | Pharmacokinetics

Access this international scientific guideline

TGA annotations

Guideline 3BS11a has been withdrawn, as explained in the above Question and Answer Guideline; however, the guidance contained within Guideline 3BS11a remains applicable in Australia, as in the EU, and has been incorporated into TGA Guidance 23: Nonclinical studies.

For more information see International scientific guidelines adopted in Australia.

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.