10+ Bsr Infratech India Interview Questions and Answers

Notify the appropriate personnel immediately and follow the standard operating procedure for handling damaged or non-functional equipment.

• Check the temperature of the freezer and record it.

• Transfer the contents of the freezer to a backup freezer or a temporary storage unit.

• Notify the supervisor or the maintenance team immediately.

• Follow the standard operating procedure for handling damaged or non-functional equipment.

• Document the incident and the actions taken in the appropri...read more

Pharmacodynamics is the study of how drugs affect the body, while pharmacokinetics is the study of how the body affects drugs.

• Pharmacodynamics focuses on the drug's mechanism of action and its effects on the body

• Pharmacokinetics focuses on how the body absorbs, distributes, metabolizes, and excretes drugs

• Understanding pharmacodynamics and pharmacokinetics is important in determining the appropriate dosage and potential side effects of a drug

• Examples of pharmacodynamics includ...read more

Informed consent is the process of obtaining permission from a patient or participant after providing them with all relevant information about a medical procedure or research study.

• Informed consent involves providing detailed information about the purpose, risks, benefits, and alternatives of a medical procedure or research study.

• The patient or participant must have the capacity to understand the information provided and make an informed decision.

• Informed consent should be vo...read more

Bioequivalence/bioavailability studies compare the pharmacokinetics of two formulations of a drug.

• Bioequivalence studies compare the rate and extent of absorption of a test drug to a reference drug

• Bioavailability studies measure the amount of a drug that enters the bloodstream and the rate at which it does so

• These studies are important for ensuring that generic drugs are equivalent to their brand-name counterparts

• They can also be used to compare different formulations of the ...read more

BA/BE studies are bioavailability and bioequivalence studies used to compare the pharmacokinetic properties of two drugs.

• BA/BE studies are conducted to determine if a generic drug is equivalent to the brand-name drug in terms of safety and efficacy.

• Bioavailability refers to the rate and extent to which a drug is absorbed into the bloodstream.

• Bioequivalence refers to the similarity in the rate and extent of drug absorption between two formulations of the same drug.

• BA/BE studie...read more

Phase-2 in clinical trials involves testing the drug or treatment on a larger group of people to determine its effectiveness and safety.

• Phase-2 typically includes a few hundred participants.

• The main goal is to further evaluate the drug's safety and effectiveness.

• Dosing and potential side effects are closely monitored.

• Results from Phase-2 trials help determine if the drug should move on to Phase-3 trials.

There are 4 clinical trial phases.

• Phase 1: Small group of healthy volunteers to test safety and dosage

• Phase 2: Larger group to test effectiveness and side effects

• Phase 3: Even larger group to confirm effectiveness and monitor side effects

• Phase 4: Post-marketing studies to monitor long-term effects and compare to other treatments

Assist investigators by providing administrative support, ensuring compliance with regulations, and facilitating communication.

• Provide administrative support such as scheduling appointments and organizing study materials

• Ensure compliance with regulations by maintaining accurate records and monitoring study progress

• Facilitate communication between investigators, study staff, and participants

• Assist with data collection and analysis

• Help with study recruitment and retention effor...read more

A clinical trial is a research study conducted to evaluate the safety and effectiveness of new medical treatments or interventions.

• Clinical trials involve human participants who volunteer to test new drugs, devices, or procedures.

• They are conducted in phases to assess different aspects such as safety, dosage, and efficacy.

• Participants are closely monitored by healthcare professionals to ensure their well-being and the accuracy of the results.

• Results from clinical trials help ...read more

Clinical trial phases are the stages of testing a new drug or treatment in humans.

• Phase 1: Small group of healthy volunteers to test safety and dosage

• Phase 2: Larger group of patients to test effectiveness and side effects

• Phase 3: Even larger group to confirm effectiveness, monitor side effects, and compare to existing treatments

• Phase 4: Post-marketing surveillance to monitor long-term safety and effectiveness

LAR stands for Legally Authorized Representative, a person designated to make medical decisions for a patient who is unable to do so themselves.

• LAR is appointed when a patient is unable to make their own medical decisions

• The LAR must act in the best interest of the patient

• Examples of LARs include a family member, legal guardian, or healthcare proxy

Different diseases and their pathophysiology

• Cancer: uncontrolled cell growth and division

• Diabetes: high blood sugar due to insulin resistance or deficiency

• Alzheimer's: progressive brain disorder leading to memory loss and cognitive decline

• Asthma: chronic inflammation of airways leading to breathing difficulties

• Heart disease: narrowing or blockage of blood vessels leading to heart attack or stroke

I have extensive experience in preparing and submitting regulatory documents for approval.

• Managed the submission process for multiple projects, ensuring compliance with regulations

• Worked closely with regulatory agencies to address any issues or concerns

• Reviewed and edited submission documents to ensure accuracy and completeness

• Successfully obtained approval for X number of projects within specified timelines

I have extensive experience in monitoring project progress, identifying risks, and implementing corrective actions.

• Regularly tracking project milestones and deliverables

• Identifying potential risks and developing mitigation strategies

• Implementing changes to project plans as needed to ensure successful completion

• Utilizing project management software to monitor progress and communicate updates

• Holding regular status meetings with team members to discuss progress and address any i...read more