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Question 1 Describe all the five scenarios as recommended by Mashelkar's task force for biopharmaceuticals
Question 2 Write in detail about scientific review required in US for the medical devices for which insufficient information exists to assure safety and effectiveness
Question 3 List out the procedures for filing a 510(k) application and a Pre-market approval application for medical devices in the USA
Question 4 What is the significance of ‘immunogenicity' in safety testing of a biosimilar product? What is the scope and purpose of the guidelines pertaining to the quality issues of the biosimilar product?
Question 5 Describe the procedure for import of cosmetics in US and India
Question 6 Enumerate functions of
Objectives : After studying this unit, you should be able to 1. explain the need for safety and health regulations using an example, 2. describe the use of National Buildi
Explain Automaticity - Properties of a Beating Heart Take out my heart from my body and it will still go on and on beating. How true! Even a completely denervated heart eom the
Question 1 Differentiate between types of clinical trials and bring out the importance of SAD Studies and MAD Studies Question 2 What is the difference between randomization
Greenhouse effect: Scientists have reason to believe that air pollution. both due to carbon particles or soot and carbon dioxide would affect weather. A rise in surface temper
A model reaction water turbine Use a soda water bottle from which the bottom has been separate. Wind string around it near the bottom end and suspend it as shown in the diagram
Explain the Aplastic Anaemia Bone marrow aplasia means 'lack of functioning of bone marrow'. This can occur due to excessive X-ray or radiation treatment, certain industrial ch
advantages and disadvantages of protozoa
Explain Haemophilia Haemophilia is a disease characterized by excessive bleeding due to deficiency of clotting factor VIII. The patient need repeated blood transfusion or may
What is the significance of soil colour Soil colour is significant in soil classification, i.e. the characterisation of soil, interpreting soil properties and understanding so
Lead Times of Scientific Development: When we compare the current status of scientific development and technological fall-out from the same, we find that the lead time of scien
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