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Question 1 Describe all the five scenarios as recommended by Mashelkar's task force for biopharmaceuticals
Question 2 Write in detail about scientific review required in US for the medical devices for which insufficient information exists to assure safety and effectiveness
Question 3 List out the procedures for filing a 510(k) application and a Pre-market approval application for medical devices in the USA
Question 4 What is the significance of ‘immunogenicity' in safety testing of a biosimilar product? What is the scope and purpose of the guidelines pertaining to the quality issues of the biosimilar product?
Question 5 Describe the procedure for import of cosmetics in US and India
Question 6 Enumerate functions of
Explosives : These include the commercial explosives, preparations and substances used as blasting agents, ammunition, fireworks etc. Some examples are, gun powder, chlorate mixtu
INTRODUCTION : In any science lab you work with chemicals, gases, electrical equipments, glassware, instruments etc. In case you are working in a biology laboratory handling the p
Define Oxytocin Hormone - Posterior Pituitary Oxytocin is a polypeptide containing 9 amino acids. An 'oxytoxic' agent is a substance that causes the gravid uterus (uterus of a
what is thermal velocity ofa material
Physico-chemical properties of vitamin E are as follows: a) Tocopherols are yellow, oily liquids. b) They are freely soluble in fat solvents. c) The compounds are
Define Pollutants Regulated Under the Clean Water Act? The Federal Water Pollution Control Act (FWPCA) Amendments of 1972 later amended while the Clean Water Act (CWA) organize
What is the common name for the test that provides the hardness of the material by the size of an indent left in it by a standard steel ball? The Brinell Test
What is the minimum depth required for a feature to be considered a canyon? In fact, it is a bit like allowing for when a few grains of sand become a heap of sand: there is no
what are all about diastrophism ?
INTRODUCTION : By doing this exercise, you will learn how to deal with emergency situations arising out of laboratory accidents. You are aware that a tense situation arises once a
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