Guidance 15: Biopharmaceutic studies

Book pagination

(Previously ARGPM 15: Biopharmaceutic studies)

2 April 2015

Version 1.1 April 2015

Check the TGA website for up-to-date guidance

The most up-to-date- information about prescription medicine registration in Australia is on the TGA website. Now that guidance is presented in a series of web pages, updates are likely to be more common than in the past. If you subscribe to the TGA guidelines email alert service, you will be emailed every time the TGA web guidance is updated.TGA web pages are dated, and can be printed.

A PDF format is being provided during the transition between the former version of the ARGPM (Australian Regulatory Guidelines for Prescription Medicines) and the new web format. Please note that information in the PDF should not be relied upon to be up-to-date.

This guidance is to assist sponsors of prescription medicines to prepare applications to:

  • register new prescription medicines on the ARTG
  • vary the registration of a prescription medicine on the ARTG.

This guidance covers:

  • all matters relating to bioavailability  and/or bioequivalence aspects of prescription medicines containing active substances that are synthetic chemical entities
  • active substances that are:
    • antibiotics
    • short-chain synthetic polypeptides
  • some hormones (steroid hormones and synthetic peptides of usually less than 32 amino acids-some exceptions may apply).

This guidance does not cover:

  • Matters relating to other pharmacokinetic studies.

Contents

Version history

Version Description of change Author Effective date
V1.0 Original Publication Office of Medicines Authorisation 1 July 2014
V1.1 Minor text update Scientific Evaluation and Special Product Access Branch 1 April 2015

Book pagination