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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.
Define Precautions for Check the Presence of Rhodamine B? 1. Sample should be clean and dry. 2. Dispose off the paraffin oil carefully, so that it does not contaminate food/
what is the difference between anisogamy and oogamy?
Define Significance and Impact of Plants and Animals on Human Life? Plants and animals both have a great significance and unparalleled impact on human life. Most of our needs a
A female Drosophila with singed bristles is crossed to a male with sepia (dark brown) eyes. In the F1, all females are wild-type and all males have singed bristles. F1 males and fe
Nerve Cell - The Basic Unit The basic unit of the nervous system is the nerve cell or neuron. A neuron is to the nervous system what a brick is to the building. It has a cell
Q. Show overall management of diabetes? Diabetes as we all know is a disease with ever increasing prevalence in' our country. It can be described as a disease characterized by
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Gene targeting in somatic cells: Since the pioneering work with sheep at Roslin cloning by nuclear transfer has now been exemplified in a number of other livestock species includ
Explain the difference between endoparasite, ecctoparasite, and parasitoidism
How do we Treat Protein Energy Malnutrition? Major objective of the treatment of PEM is to provide adequate energy and protein intake and control infections, if any. Mild and m
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