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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.
Q. Evaluate the texture of various foods? A number of instruments are available to evaluate the texture of various foods. Brief discussions on these instruments follow. Cons
Congenital Anomalies of Small and Large Intestines: 1) Intussusecption Intussusecption is the invagination or telescoping of one part of the intestine into another part
Define the Feeding and Nutritional Management of spinal trauma? The main objectives of nutritional management are to meet the nutritional needs of the initial acute phase and
Estuaries - Aquatic Ecosystems All the rivers and lakes ultimately drain into the sea. However, many rivers develop a highly specialised zone before joining the proper sea. Th
Insulin, insulin syringe and insulin devices Insulin is the hormone used to treat diabetes mellitus. Insulin is given in the form of injection, because the gastro intestinal tr
Define the Chemical Fixation Method? Here chemical fixatives containing ethanol, acetic acid and formaldehyde etc. penetrates the cell and inactivates and immobilizes cellular
Q. Describe the Morphological Characteristics? One of the first steps in the identification of bacteria in food is microscopic examination to ascertain the shape, size, aggreg
Primitive Arthropods The primitive arthropods, Onychophora (for example Peripatus) have a series of paired legs which are not jointed but have a ringed appearance because of t
Determine the following term - Amniote egg Eggs that shelter the developing embryo in a water-filled sac—the amnion. Characteristic of the amniote animals, which include reptil
Somatic Embryogenesis The process of embryo development is called embryogenesis. It is not the monopoly of the egg to form an embryo. Any cell of the female gametophyte (Embr
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