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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.
You observe the following numbers of individuals of each genotype in a population: AA 700 Aa 200 aa 100 a.) what are the observed genotype frequencies in this populaiton?
Give one example in each case of (a) a fixed joint, (b) a ball and socket joint, (c) a hinge joint. (a) The bones of the skull, the junction of pelvic gi
What are phospholipids? Phospholipids are molecules made of glycerol bound to two long molecules of fatty acids and to one phosphate group. Thus, phospholipids are amphipathic
Sickle cell anaemia in man is caused by a defective chain of haemoglobin. The abnormal haemoglobin known as MbS differs from natural haemoglobin (HhA) in one amino acid. A substitu
Definition of probiotics and prebzotics? An early definition of probiotics is 'organisms and substances which contribute to intestinal microbial balance'. Later the word 'subst
Coronal Disassembly -If the existing restoration functionally designed well fitting and esthetically pleasing , -The access the pulp chamber during retreatment is better app
Ed e m a It refers to excessive accumulation of fluid in tissue spaces caused by disturbance in the fluid interchange between capillaries, tissue spaces and lymphatic vessel
During residency: This alters from program to program depending on the number of sites covered and number of residents. At McMaster, we do call roughly 1 in 7 or 8 (averages out to
The interactions between the human host and selected microorganisms that culminate in IE involve the vascular endothelium, hemostatic mechanisms, the host immune system, gross anat
What is the difference between brain and cerebrum? What are the main parts of these structures? The concept of brain, or encephalon, comprehends the cerebrum (mostly referred t
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