The EMA, The European Drug Regulator, Published Q&A on ICH Topic E7, Studies in Support of Special Populations: Geriatrics Step 5
Full Text Here
Why do we need an adequate representation of geriatric patients in the clinical database?
What should be taken into account when estimating an adequate representation of geriatric patients to be included in the clinical database?
Are there any special patient populations or characteristics that are particularly important to address in the planning of the clinical development program?
What should be considered for the clinical development program to adequately characterize the safety and efficacy of a drug for a marketing application?
Are there concerns related to the data specific to the geriatric population that could be considered in the planning of the clinical studies?
In light of recent advances in the field of pharmacokinetics and assessment of drug-drug interactions since the ICH E7 guideline was established, what studies should be considered when developing a drug that will be used in geriatric patients?
To Access A Drug Development Expert Click Here
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
