To ensure compliance with regulatory requirements

To develop new drugs and treatments

To conduct clinical trials

To market and sell pharmaceutical products

Central Drugs Standard Control Organization (CDSCO)

Food and Drug Administration (FDA)

European Medicines Agency (EMA)

World Health Organization (WHO)

To provide detailed information about a drug substance or active pharmaceutical ingredient (API)

To submit a new drug application (NDA)

To conduct a clinical trial

To obtain a marketing authorization

An NDA is for a new drug, while an ANDA is for a generic drug

An NDA requires clinical trials, while an ANDA does not

An NDA is more complex and expensive to file than an ANDA

All of the above

To evaluate the safety and efficacy of a new drug or treatment

To obtain marketing authorization for a new drug or treatment

To compare different drugs or treatments

All of the above

Phase I, Phase II, and Phase III

Phase I, Phase II, Phase III, and Phase IV

Phase I, Phase II, Phase III, Phase IV, and Phase V

Phase I, Phase II, Phase III, Phase IV, and Phase VI

To allow a pharmaceutical company to sell a new drug or treatment

To ensure that a new drug or treatment is safe and effective

To protect the public from unsafe or ineffective drugs or treatments

All of the above

A generic drug is a copy of a brand-name drug

A generic drug is typically less expensive than a brand-name drug

A generic drug contains the same active ingredients as a brand-name drug

All of the above

To monitor the safety of drugs and vaccines after they have been marketed

To identify and manage adverse drug reactions

To prevent adverse drug reactions from occurring

All of the above

A recall is issued when a drug or vaccine is found to be unsafe or ineffective

A withdrawal is issued when a drug or vaccine is found to be unsafe or ineffective

A recall is issued when a drug or vaccine is found to be unsafe or ineffective, while a withdrawal is issued when a drug or vaccine is found to be ineffective

A recall is issued when a drug or vaccine is found to be unsafe or ineffective, while a withdrawal is issued when a drug or vaccine is found to be unsafe

To ensure that drugs and vaccines are manufactured in a safe and consistent manner

To prevent contamination of drugs and vaccines

To ensure that drugs and vaccines meet the required standards of quality

All of the above

A batch record is a document that describes the manufacturing process of a drug or vaccine

A certificate of analysis is a document that certifies that a drug or vaccine meets the required standards of quality

A batch record is a document that describes the manufacturing process of a drug or vaccine, while a certificate of analysis is a document that certifies that a drug or vaccine meets the required standards of quality

A batch record is a document that certifies that a drug or vaccine meets the required standards of quality, while a certificate of analysis is a document that describes the manufacturing process of a drug or vaccine

To determine the shelf life of a drug or vaccine

To ensure that a drug or vaccine is stable under different storage conditions

To identify any potential degradation products of a drug or vaccine

All of the above

A bioavailability study measures the amount of a drug that reaches the bloodstream

A bioequivalence study compares the bioavailability of two different drugs or formulations

A bioavailability study measures the amount of a drug that reaches the bloodstream, while a bioequivalence study compares the bioavailability of two different drugs or formulations

A bioavailability study compares the bioavailability of two different drugs or formulations, while a bioequivalence study measures the amount of a drug that reaches the bloodstream

To evaluate the safety and efficacy of a new drug or treatment in humans

To determine the pharmacokinetic and pharmacodynamic properties of a new drug or treatment

To identify any potential drug interactions

All of the above