Drug Vs Device - part 1
Dr. Ashish Indani
Regd. Independent director| MedTech clinical Regulatory, R&I| opinions & posts are my personal | Key Opinion Leader in #MedicalDevices | Author | Tedx Speaker
Medical Devices are essentially different from the drugs in many matters as devices fail differently. However, the current Clinical Research industry is obviously catering majorly to the science of drugs. Hence, the clinical research knowledge from drugs world requires realignment and reskilling before it applies to the medical devices. The first main difference if the fundamental difference between drugs and devices. Drugs need 3 phases of clinical trials, device may not need any of these. Drugs are more predictable than devices. Devices can not be tested on healthy individuals and their animal studies (if its relevant to conduct) are not sufficient to provide accurate data of performance.
How does it translate into differences of implementation and application - Watch for next part.
#MedicalDevices #MedicalDevice #EssentialsOfMedicalDeviceCR #ClinicalResearch
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1yVery useful thanks for sharing
Providing #article for journal #publication, #presentation for #medicaleducation and #CME, #medcomms, #medicalwriting #digitalmarketing, and #medicalaffairs solutions for #pharma and #medicaldevices
1yVery well summarised
Pharmacovigilance | Quality Management Systems | Good Distribution Practices for Pharmaceutical Products
1yThanks Dr. Ashish Indani. I was discussing with a colleague earlier today about cCGMP guidelines. Are the cGMP guidelines for medicines also applicable to medical devices?
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1y"Brilliantly Simplified!" Bhishampitamah of device regulations.