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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.
Explain the pair of chromosomes and Sex Chromosomes? Morgan also noticed that one pair of chromosomes is different in male and female flies, one of the male chromosomes being
Explain Carbohydrates - Nutritions? Liberal amounts of carbohydrates should be given i.e. around 60% to 65% of the total energy. However, care must be taken regarding the maxim
What is the Vacuum Puff Drying? The vacuum puff process has been developed for drying liquids under vacuum. The development of processes for drying liquids under vacuum came fr
Why do roots of many swamp plants have a special morphology? Swamp and marsh plants usually present supporting roots that ramify from portions of the stem above the ground help
Q. How Tyndallisation used for sterilization? John Tyndall devised a process of sterilisation by steaming for a few minutes at 100 o C on 3-4 successive operations separated by
Explain Diabetic diets Diabetic diets : There are therapeutic modification in the quantity1 quality of various macronutrients particularly carbohydrates.
Q. Which are the groups of living beings that form the protist kingdom? The protist kingdom includes algae and protozoans. (Two groups of fungi with similar characteristics to
Determine the function of Iron for athletes? Iron carries oxygen and is another important mineral for athletes. It also affects oxygen transport and aerobic metabolism as a com
Which of the following serves as an actuating signal, or as part of an actuating signal, in a positive feedback system? A. Blood plasma levels of PTH (Parathryroid Hormone).
similarity between pisces & mammals about dirhynous condition......
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