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Question 1:
Describe upon CMC information about drug substance to be submitted to IND for Phase 3 studies.
Definition of CMC
Explain about CMC information about drug substance to be submitted to IND for Phase 3 studies-General Information, Manufacturers,
Description of Manufacturing Process and Process Controls, Controls of Critical Steps and Intermediates, Characterization, Control of Drug Substance, Reference Standards or Materials, Container Closure System, Stability, Control of Materials.
Question 2:
Prepare a scientific review required in US for the medical devices for which insufficient information exists to assure safety and effectiveness.
Alfieri Repair: This is advised for ischaenlic mitral regurgitation. In the area of prolapse, the anterior and posterior leaflet edges are approximated with one or two mattress
Explain Proteins as lubricants? The mucous of the respiratory tract, oral cavity, vaginal tract and the rectal cavity reduces the irritation which might be caused by materials
Describe the term Humidification Dry gases result in the loss of ciliary activity of the mucosa of the airway and can lead to mucosal damage as well as causing the secretions
What is root pressure? Root pressure is the pressure that forces water from the soil to be absorbed by the xylem of the root. It is because of the osmotic gradient among the i
B o v i ne ephemeral fever Ephemeral fever is commonly known as 'three-day sickness'. It affects mainly cattle and occasionally sheep in India. Causative agent is a mosquit
Q. What are risk factors for diseases? The Risk factors for a disease are everything that contributes to increase the risk of the disease to appear. For example, for most cardi
What is the mode of nutrition in fish,human,amoeba,scorpian & toad
Q. Etiological factors involved in short bowel syndrome? The etiological factors involved in this disease are: • Anaemia • Osteoporosis • Stone formation • Decrease
How are the concepts of DNA, gene, proteins and characteristics of living beings related? Characteristics of organisms depend on chemical reactions that happen in them. These r
Q. Is pollution always caused by humans? In the most cases pollution is caused by human activity. Other species and some abiotic factors though can also pollute an ecosystem. F
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