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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.
Q. How do kidneys participate in the regulation of the acid-basic equilibrium of the body? How are alkalosis and acidosis respectively corrected by the kidneys? Kidneys can reg
example of pisces
Define Absorption of Dietary Iron? Haem iron is more bioavailable than non-haem iron because it is absorbed intact as a soluble complex by endocytosis (process whereby cells ab
Biological energy: Whenever matter is broken down its chemical energy is released as heat. Non biological system can utilize this heat energy directly in the performance of work,
Adrenal glands There are two adrenal glands one each on the top of each kidney. Adrenal gland has two parts, the outer cortex and inner medulla. Both cortex and medull
Define Potential Health benefits from resistant starch? Like dietary fibre, RS can also play a potential role in helping to maintain or improve health of an individual. As you
Autotomy and Regeneration Shedding of body parts in self-defense to avert the attention of the predator-enemy or in any other emergency is a type of autotomy (auto: self, tom
Define the Dietary Sources and Chemical Forms? Isoflavones and coumestans are the most common compounds. Soybeans and soyfoods are the most important sources, containing approx
Response to Heavy Metal Stress Several heavy metals emanating from industrial mining and sewage disposal operations contaminate the environment. Cadmium is a common contamina
Define Proteins as regulators of water balance? As substrates and solutes are transferred or exchanged across membranes, water has a tendency to follow to maintain equal osmoti
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