A Paediatric Investigation Plan (PIP) must be submitted in order to support a medicine's authorisation for use in children. The PIP undergoes a review process and ensures that paediatric...
Bioavailability is the fraction (percentage) of an administered dose of unchanged drug that reaches the blood stream (systemic circulation). Bioavailability varies between different pharmaceutical ingredients and mode of administration.
During the non-clinical safety testing step of the medicines discovery and development process, molecules undergo safety testing in animal subjects in order to determine whether or not they are...
Risk communication is a two-way exchange of information on the risks and benefits of a medicine. Patients, companies, and health authorities all have important roles to play in risk...
Introduction A case report on patients recruited by Janssen R&D in a program constructed for the EATG members. Afterwards, the course was handed over for further capacity building within...
Traditionally, health data has been generated by documenting patients’ records (i.e. clinicians’ notes, lab results, prescriptions etc.) in a paper-based system. However, this system has several challenges such as...
How early in the development of a new medicine should thEarly collaboration - a recipe for solutions: drug development and treatment strategies may go hand in hand.e discussion between...
The starter kits provide you with links to relevant background reading in the toolbox and associated PowerPoint slide decks and media in order to prepare a single or multi-day...
Transcription My name is Jan Geissler. I’m a patient advocate now for fifteen years. I’ve been diagnosed with chronic myeloid leukemia in 2001. At that time, diagnosis really...
