1. Fair play to the UK ABPI for pitching its new Phase I guidance at trial volunteers, instead of just targeting sponsors and investigators. The preface celebrates the fact volunteers used the 2007 version and the update continues with the inclusive tone. Details such as the above table - which gives a brief but clear summation of the four phases of clinical trials - are a positive move. The guidance also has an extensive glossary and links to other relevant websites. You can download the document here.
    High Res

    Fair play to the UK ABPI for pitching its new Phase I guidance at trial volunteers, instead of just targeting sponsors and investigators. The preface celebrates the fact volunteers used the 2007 version and the update continues with the inclusive tone.

    Details such as the above table - which gives a brief but clear summation of the four phases of clinical trials - are a positive move. The guidance also has an extensive glossary and links to other relevant websites. You can download the document here.

    August 17, 2012