PHARMACEUTICS_MODULE 1_INTRODUCTION TO DRUGS AND PHARMACY

Used in pharmacy and the pharmaceutical sciences to encompass a wide range of subject areas that are all associated with the steps to which a drug is subjected towards the end of its development.

PHARMACEUTICS

It encompasses the stages that follow on from the discovery or synthesis of the drug, its isolation and purification, and its testing for beneficial pharmacological effects and absence of serious toxicological problems.

PHARMACEUTICS

converts a drug into medicine

PHARMACEUTICS

An agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease.

DRUG Signup and view all the answers

A formulation that typically contains the API(s) and excipients in quantities and physical form design to facilitate the accurate and efficient administration of the API to the human or animal patient,

DOSAGE FORMS Signup and view all the answers

Modern technology, distributed with or as part of a drug product that allows for the uniform release or targeting of drugs to the body.

DRUG DELIVERY SYSTEMS Signup and view all the answers

refers to the variability in response to drug therapies in humans

PHARMACOGENETICS Signup and view all the answers

Many genetic and non-genetic factors affect the way we respond to therapies

True Signup and view all the answers

Factors such as cultural, behavioral, and environmental could have an enormous impact on the extent of these variations

True Signup and view all the answers

Genetic factors account for up to ___% in the variations in response to treatment.

95% Signup and view all the answers

Need for higher or more frequent doses of drugs that are acetylated (eg, isoniazid) to produce the desired therapeutic response

Acetylation, fast Signup and view all the answers

Increased susceptibility to adverse effects of drugs that are acetylated (eg, with isoniazid, peripheral neuritis; with hydralazine or procainamide, lupus)

Acetylation, slow (drug inactivation by hepatic N-acetyltransferase) Signup and view all the answers

With alcohol ingestion, marked elevations of blood acetaldehyde, causing facial flushing, increased heart rate, diaphoresis, muscle weakness, and sometimes catecholamine-mediated vasodilation with euphoria

Aldehyde dehydrogenase-2 deficiency Signup and view all the answers

Reduced enzymatic activation of clopidogrel, resulting in reduced antiplatelet effect and increased risk of thrombosis in high-risk patients

CYP2C9 genetic polymorphisms Signup and view all the answers

With use of oxidant drugs, such as certain antimalarials (eg, chloroquine, primaquine), increased risk of hemolytic anemia

G6PD deficiency Signup and view all the answers

is an important example of the field of precision medicine, which aims to tailor medical treatment to each person or to a group of people.

PHARMACOGENOMICS Signup and view all the answers

looks at how your DNA affects the way you respond to drugs.

PHARMACOGENETICS Signup and view all the answers

can improve your health by helping you know ahead of time whether a drug is likely to benefit you and be safe for you to take.

PHARMACOGENETICS Signup and view all the answers

The study of genetic causes of individual variations in drug response

PHARMACOGENETICS Signup and view all the answers

The simultaneous impact of multiple mutations in the genome that may determine the patient’s response to drug therapy.

PHARMACOGENOMICS Signup and view all the answers

studies use information contained in metabolic profiles (or metabolome) to inform about how a subject will respond to drug treatment.

PHARMACOMETABOLOMICS Signup and view all the answers

Genome, gut microbiome, sex, nutrition, age, stress, health status, and other factors can impact the metabolic profile of an individual.

True Signup and view all the answers

Metabolomic profiles obtained prior to, during, or after drug treatment could provide insights about drug mechanism of action and variation of response to treatment.

True Signup and view all the answers

Build models to predict individual drug pharmacokinetic/pharmacodynamic probabilities

BASELINE METABOTYPE Signup and view all the answers

Build models based on the actual drug pharmacokinetic/pharmacodynamic response(s) by an individual or group

TREATMENT METABOTYPE Signup and view all the answers

An individual’s metabolic profile has been referred to as his or her _________

METABOTYPE Signup and view all the answers

Is a field of science focusing on studying the effect of biological rhythms on pharmacotherapy, i.e., a branch of pharmacology studying the dependencies between the timing of drug administration and its effect.

CHRONOPHARMACOLOGY Signup and view all the answers

___________ are self-supporting oscillations of physiological phenomena generated and controlled by endogenic “biological clocks”, characterized by repeatability.

BIOLOGICAL RHYTHMS Signup and view all the answers

A self-evident physiological feature of living organisms is the fact that biological phenomena are not invariable over time, but manifest rhythmicity—at the systemic, organ, and cellular level.

True Signup and view all the answers

Which two substances react to create the pharmaceutical mixture known as ELIXIR?

Sulfanilamide and Diethylene glycol Signup and view all the answers

Creation of the ____ is to administer and enforce FD&C ACT of 1938

FDA Signup and view all the answers

Prohibits the distribution and use of any new drug or drug product without the prior filing of a new drug application (NDA) and approval of the FDA.

THE FEDERAL FOOD, DRUG, AND COSMETIC ACT OF 1938 Signup and view all the answers

Which law includes the statement: "Caution: Federal Law Prohibits Dispensing Without Prescription."?

DURHAM-HUMPHREY AMENDMENT OF 1952 Signup and view all the answers

New drug is required to file an investigational new-drug application (IND) with the FDA before the drug may be clinically tested on human subjects

KEFAUVER-HARRIS AMENDMENTS OF 1962 Signup and view all the answers

What condition is associated with the use of Thalidomide?

Phocomelia Signup and view all the answers

New drug is required to file an investigational new-drug application (IND) with the FDA before the drug may be clinically tested on human subjects

KEFAUVER-HARRIS AMENDMENTS OF 1962 Signup and view all the answers

Which federal act serves to consolidate and codify control authority over drugs of abuse into a single statute, is administered by the Drug Enforcement Administration (DEA), and established five schedules with decreasing levels of control?

THE FEDERAL FOOD, DRUG, AND COSMETIC ACT OF 1938 Signup and view all the answers

Drugs with no accepted medical use, or other substances with a high potential for abuse.

SCHEDULE 1 Signup and view all the answers

Drugs with accepted medical uses and a high potential for abuse that if abused may lead to severe psychologic or physical dependence

SCHEDULE 2 Signup and view all the answers

Drugs with accepted medical uses and a potential for specified quantities of codeine, abuse less than those listed in schedules I and Il that if abused may lead to moderate psychologic or physical dependence.

SCHEDULE 3 Signup and view all the answers

Drugs with accepted medical uses and low potential for abuse relative to those in Schedule Ill that if abused may lead to limited physical dependence or psychologic dependence relative to drugs in schedule Ill.

SCHEDULE 4 Signup and view all the answers

Drugs with accepted medical uses and low potential for abuse relative to those in schedule IV that if abused may lead to limited physical dependence or psychologic dependence relative to drugs in schedule IV.

SCHEDULE 5 Signup and view all the answers

The Pregnancy Category 'X' indicates that a drug is contraindicated during pregnancy due to:

Risk of teratogenic effects Signup and view all the answers

The FDA has established _____ categories that can be used to estimate the potential of a systemically absorbed drug for causing birth defects.

5 Signup and view all the answers

Appropriate human studies - no risk

PREGNANCY CATEGORY A Signup and view all the answers

Insufficient human studies, but animal research suggests safety or: Animal studies show issues but human studies show safety

PREGNANCY CATEGORY B Signup and view all the answers

Insufficient human studies, but animal studies show problems or: No animal studies, and insufficient human studies

PREGNANCY CATEGORY C Signup and view all the answers

Human studies, with/without animal research show fetal risks, but the drug is important to some women to treat their conditions

PREGNANCY CATEGORY D Signup and view all the answers

Fetal risks are evident; there are no situations where the risk/benefit justifies use

PREGNANCY CATEGORY X Signup and view all the answers

Marketed product that presents a threat or a potential threat to consumer safety

PRODUCT RECALL Signup and view all the answers

Reported problems may include product defects, product adulteration, container leakage, improper labeling, unexpected adverse reactions, and others.

PRODUCT RECALL Signup and view all the answers

[Product Recall Classification] There is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

CLASS 1 Signup and view all the answers

[product recall classification] The use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote.

CLASS 2 Signup and view all the answers

PHARMACEUTICS_MODULE 1_INTRODUCTION TO DRUGS AND PHARMACY

Questions and Answers

Used in pharmacy and the pharmaceutical sciences to encompass a wide range of subject areas that are all associated with the steps to which a drug is subjected towards the end of its development.

It encompasses the stages that follow on from the discovery or synthesis of the drug, its isolation and purification, and its testing for beneficial pharmacological effects and absence of serious toxicological problems.

converts a drug into medicine

An agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease.

A formulation that typically contains the API(s) and excipients in quantities and physical form design to facilitate the accurate and efficient administration of the API to the human or animal patient,

Modern technology, distributed with or as part of a drug product that allows for the uniform release or targeting of drugs to the body.

refers to the variability in response to drug therapies in humans

Many genetic and non-genetic factors affect the way we respond to therapies

Factors such as cultural, behavioral, and environmental could have an enormous impact on the extent of these variations

Genetic factors account for up to ___% in the variations in response to treatment.

Need for higher or more frequent doses of drugs that are acetylated (eg, isoniazid) to produce the desired therapeutic response

Increased susceptibility to adverse effects of drugs that are acetylated (eg, with isoniazid, peripheral neuritis; with hydralazine or procainamide, lupus)

With alcohol ingestion, marked elevations of blood acetaldehyde, causing facial flushing, increased heart rate, diaphoresis, muscle weakness, and sometimes catecholamine-mediated vasodilation with euphoria

Reduced enzymatic activation of clopidogrel, resulting in reduced antiplatelet effect and increased risk of thrombosis in high-risk patients

With use of oxidant drugs, such as certain antimalarials (eg, chloroquine, primaquine), increased risk of hemolytic anemia

is an important example of the field of precision medicine, which aims to tailor medical treatment to each person or to a group of people.

looks at how your DNA affects the way you respond to drugs.

can improve your health by helping you know ahead of time whether a drug is likely to benefit you and be safe for you to take.

The study of genetic causes of individual variations in drug response

The simultaneous impact of multiple mutations in the genome that may determine the patient’s response to drug therapy.

studies use information contained in metabolic profiles (or metabolome) to inform about how a subject will respond to drug treatment.

Genome, gut microbiome, sex, nutrition, age, stress, health status, and other factors can impact the metabolic profile of an individual.

Metabolomic profiles obtained prior to, during, or after drug treatment could provide insights about drug mechanism of action and variation of response to treatment.

Build models to predict individual drug pharmacokinetic/pharmacodynamic probabilities

Build models based on the actual drug pharmacokinetic/pharmacodynamic response(s) by an individual or group

An individual’s metabolic profile has been referred to as his or her _________

Is a field of science focusing on studying the effect of biological rhythms on pharmacotherapy, i.e., a branch of pharmacology studying the dependencies between the timing of drug administration and its effect.

___________ are self-supporting oscillations of physiological phenomena generated and controlled by endogenic “biological clocks”, characterized by repeatability.

A self-evident physiological feature of living organisms is the fact that biological phenomena are not invariable over time, but manifest rhythmicity—at the systemic, organ, and cellular level.

Which two substances react to create the pharmaceutical mixture known as ELIXIR?

Creation of the ____ is to administer and enforce FD&C ACT of 1938

Prohibits the distribution and use of any new drug or drug product without the prior filing of a new drug application (NDA) and approval of the FDA.

Which law includes the statement: "Caution: Federal Law Prohibits Dispensing Without Prescription."?

New drug is required to file an investigational new-drug application (IND) with the FDA before the drug may be clinically tested on human subjects

What condition is associated with the use of Thalidomide?

New drug is required to file an investigational new-drug application (IND) with the FDA before the drug may be clinically tested on human subjects

Which federal act serves to consolidate and codify control authority over drugs of abuse into a single statute, is administered by the Drug Enforcement Administration (DEA), and established five schedules with decreasing levels of control?

Drugs with no accepted medical use, or other substances with a high potential for abuse.

Drugs with accepted medical uses and a high potential for abuse that if abused may lead to severe psychologic or physical dependence

Drugs with accepted medical uses and a potential for specified quantities of codeine, abuse less than those listed in schedules I and Il that if abused may lead to moderate psychologic or physical dependence.

Drugs with accepted medical uses and low potential for abuse relative to those in Schedule Ill that if abused may lead to limited physical dependence or psychologic dependence relative to drugs in schedule Ill.

Drugs with accepted medical uses and low potential for abuse relative to those in schedule IV that if abused may lead to limited physical dependence or psychologic dependence relative to drugs in schedule IV.

The Pregnancy Category 'X' indicates that a drug is contraindicated during pregnancy due to:

The FDA has established _____ categories that can be used to estimate the potential of a systemically absorbed drug for causing birth defects.

Appropriate human studies - no risk

Insufficient human studies, but animal research suggests safety or: Animal studies show issues but human studies show safety

Insufficient human studies, but animal studies show problems or: No animal studies, and insufficient human studies

Human studies, with/without animal research show fetal risks, but the drug is important to some women to treat their conditions

Fetal risks are evident; there are no situations where the risk/benefit justifies use

Marketed product that presents a threat or a potential threat to consumer safety

Reported problems may include product defects, product adulteration, container leakage, improper labeling, unexpected adverse reactions, and others.

[Product Recall Classification] There is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

[product recall classification] The use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote.

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