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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 Principle for Simple Staining of Bacterial Cultures? In simple staining, a single staining agent preferably a basic dye is used. Commonly used basic stains are carbol fu
FOOD Food consists of H O, minerals, vitamins carbohydrate, lipid & protein. A person needs 1600 cal. per day. This is BMR (Basal metabolic rate). Needed 2500 cal. per
Bacteria: Bacteria have a protective covering called 'cell wall'. Beneath this. there is a plasma membrane which encloses protoplasm of the bacterium containing various types
Hazard identification We start the process of risk assessment by first identifying the hazard. The goal of hazard identification is to identification potential adverse hea
Explain Kashin Beck disease caused by selenium deficiency? Kashin Beck disease was identified to affect growing children in parts of Siberian Russia and China. It is characteri
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Q. Meaning of Gestational Diabetes Mellitus? In this type of diabetes, increased blood sugar level is first diagnosed or recognized during pregnancy. Women are not known as dia
Aortic Valvotomy : These days aortic valvotomy even in neonates and critically ill infants is done under cardio pulmonary bypass. Through a median stemotomy, ascending aorta
Q. In ancient Greece the father of Medicine, Hypocrates, described a method of diagnosing diabetes mellitus by tasting the patient's urine. What is the physiological explanation fo
Explain Principle Osazone Test or Phenylhydrazine Reaction? Phenylhydrazine reacts with carbonyl compounds in neutral or slightly acidic medium to give phenylhydrazones. These
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