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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.
What is polymorphism
Q. What is the function of keratin in the epidermis? The epidermis is the outer layer of the skin made of epithelial tissue in the epidermis there are keratin-secreting cells (
Essential Concepts of Endosseous healing 1) Osteoblast is the prime bone matrix synthesizing cell. Like most secretory cells, osteoblasts are polarized cells, and the direction
what is the latest classification of fungi
What type of athlete would have a above average reaction time please explain.
Insulin Syringes Syringes for insulin are designed for standard U-100 insulin. 1 ml of insulin has 100 standard units of insulin. Syringe has markings in insulin units it helps
Q. What is Aflatoxin? Aflatoxins are the most widely studied of all mycotoxins. Knowledge of their existence dates from 1960, when more than 100,000 turkey died in England afte
Bi-and Poly-Functional Enzymes These enzymes are generated by genes obtained by fusion of the coding regions of two or more genes encoding various enzymes. In simple words, the
Define Classification of Fats and Fatty Acids? You must be wondering in this unit on lipids why we are talking about fats and oils and not using the term lipids. Definitely whe
Phenoxyethanol is dangerous and can be absorbed through the skin - official sites for toxicity data, though, show little toxicity in man and some toxicity (irritation) with high do
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