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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.
how to determine that the phenotype of a wild type is due to the action of one or two genes?
Growing leaves in the classroom A sweet potato will make dense foliage in the classroom if it is placed in water. Set the potato, root end down, in a glass or jar and keep the
Q. What are the two groups of defense mechanisms of the body against harmful agents or foreign? What is the difference between them? The body has many defense mechanisms agains
Phototropism - Root and Shoot Morphogenesis Paratonic growth movement of part of a plant in response to light, e.g. bending of stems of indoor plants towards a window, brough
can you explain the digestive system ?
Gastrointestinal Hormones The three main mammalian gastrointestinal hormones are secretin, gastrin and cholecystokinin (CCK). There are several other hormones all peptides. Th
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Determine the biologic response The biologic response can include: i) Metabolic disturbance. ii) Inflammatory response iii) Immune response iv) Mutagenesis v) Ca
Substrates are reagent molecules upon which enzymes act. The enzyme has spatial binding sites for the attachment of its substrate. These sites are known as activation centers of
Food Applications of alginate One of the most unusual properties of the alginates has been the ability of soluble alginate salts to produce attractive, edible gels or jellies.
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