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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.
Grazing Food Chain - Food Chain Grazing food chains are quite familiar to most of us. Cow or deer grazing in a field represent a grazing food chain. Similarly, eating of phyto
Define the process of Dough Formation? You already know that gluten is the protein found in wheat. A unique property of gluten proteins of wheat grain endosperm (and to a lesse
Q. How do hormonal tests to detect pregnancy work? Laboratory tests to detect pregnancy commonly test for human chorionic gonadotropin (HCG) concentration in urine or blood sam
What is pollination? What are the main forms of pollination? The process in which pollen grains (the male gametophytes of phanerogamic plants) reach the female gametophyte is k
Q. What is hypercholeslerolaemia? Cholesterol: It is a natural component of foods such as mutton, pork, ham, sausages, lamb, chicken, eggs (yellow), whole milk, cheese, ice-cre
#question what is the diff, urogenital system of the invertebrae animal?
Define cause of vitamin a deficiency - Infections? During acute infections, vitamin A intake in preschool children is reduced due to impaired appetite and impaired vitamin A ab
Production of ATP is an endothermic reaction. How much energy in Kcal is having in 1 molecule of ATP?
What is Cost Effective Analysis? Cost effective analysis: Cost effective analysis provides for the choice of least expensive strategy at the least cost. Here the outcome is mea
Q. Explain about Coronaru Heart Diseases? Coronary heart disease is a broad term comprising of a spectrum of diseases associated with disorders of the circulation, heart muscle
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