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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 Copper Toxicity in Human? Acute copper toxicity in humans is rare and occurs due to inadvertent consumption of copper salts. Symptoms include vomiting, diarrhoea, h
Johne’s disease The disease, discovered by Heinrich A. Johne, a German bacteriologist and veterinarian, in 1905, is caused by a bacterium named Mycobacterium avium subspecies p
Define the Food Pricing? The pricing of the food products bought by the consumer is subject to multifarious factors. Each of the factors as discussed below can affect the prici
Binding site is the place on cellular DNA to which a protein (like transcription factor) can bind. Typically, binding sites may be found in the vicinity of genes, and would be inv
Give examples of both aerobic and anaerobic exercises Games like foot ball and basket ball, involve both aerobic and anaerobic exercises. As you are aware, in modern times a n
Q. Show the Peptide found in the brain? There are as many as 300 peptide neurotransmitters found in the brain. Peptide is a short protein consisting of fewer than 100 amino aci
Q Why do protease-supplying cells of the stomach and of the pancreas make only precursors of the active proteolytic enzymes? The stomach and the pancreas make zymogens of the p
why is epidermis peeledsuggest why a marine amoeba does not have a contractile vacuole
Why is glucose such a good source of energy for bacteria? 1) Glucose contains six oxygen atoms, which can be used for oxidative phosphorylation and the generation of many ATP molec
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