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Fall 2018/P3 Year' > PHRM 866 Exam 1 > Flashcards

PHRM 866 Exam 1 Flashcards

1
Q

what are some biotech products

A

peptides
proteins
gene therapy
vaccines

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2
Q

Some therapeutic applications of biotech

A

factors to affect hemtopoyetic cells and blood coagulation
interferons/cytokines (infections and cancer)
hormones and derivs
enzymes
recombinant proteins for vaccines
cell therapy

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3
Q

Recombinant definition?

A

Using cells (microorganisms or mammalian) as “factories” to produce therapeutic proteins

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4
Q

Cloning definition?

A

Turning cells into the type of high quality biotech “factory” required for therapy

Example: monoclonal antibodies

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5
Q

MOST biotech drugs are administered by ______

A

injection

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6
Q

Biotech products are generally more _____, _____, and ______

A

potent, delicate, expensive,

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7
Q 
Protein Drug Review:
Primary Struc
Secondary Struc
Tertiary Struc
Quat Struc
A

primary - chemical sequence

2nd: alpha coils or beta sheets
3rd: 3D structure
4th: multiple 3d units together

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8
Q

What aspect of protein structure results in longer circulation time in the blood?

a) Deamidation
b) Disulfide bridges
c) Tertiary structure
d) Quaternary structure
e) Glycosylation

A

E - glycosylation

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9
Q

Two examples of excipients used to enhance protein stability in injectable products in solution and in lyophilized form are ____, respectively

a) Glucose and threhalose
b) Heparin and glucose
c) Heparin and trehalose
d) Trehalose and heparin
e) Trehalose and glucose

A

C - heparin and trehalose

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10
Q

Which of these two products have higher incidence of immunogenicity in patients?

a) Epoietin (human recombinant)
b) IL-2

A

IL-2

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11
Q

Which of the follow ing is/are typically true of intramuscular (IM) administration of monoclonal antibodies (mAbs)?
A) bioavailability (F) is near 100%
B) bioavailability (F) is 50-80%
C) peak plasma concentration (Cmax) is reached in 2-5 minutes (tmax)
D) peak plasma concentration (Cmax) is reached in several days (tmax)
a) A and C
b) A and D
c) B and C
d) B and D

A

D

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12
Q

The volume of distribution (Vd) of monoclonal antibodies (mAbs) is:

a) much larger than blood volume, due to extensive extravascular binding
b) much larger than blood volume, due to FcRn (endocytic) rescue
c) approximately equal to total body w ater, reflecting distribution to aqueous fluids in the body
d) approximately equal to blood volume, since the drug is confined to the vasculature
e) none of the above

A

D - approximately equal to blood volume, since the drug is confined to the vasculature

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13
Q

Which of the follow ing two hematopoietic factors is associated with granulocytes?

a) GM-CSF
b) MGDF

A

A

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14
Q

The neutrophil count of a patient w ith neutropenia is:a) Below 180 cells/mm3

b) Below 1,800 cells/ mm3
c) Below 180 cells/cm3
d) Below 1,800 cells/ cm3
e) Below 1,600 cells/mL

A

B - b) Below 1,800 cells/ mm3

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15
Q

The majority of circulating erythropoietin is produced in the

a) liver
b) kidney
c) bone marrow
d) pancreas
e) RES

A

B - kidney

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16
Q

The follow ing is a long-acting insulin product

a) Humulin R
b) Humulin N
c) Humalog

A

B - N

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17
Q

USP <797> applies to ___________ of sterile preparations.

a) Compounding
b) Compounding and transportation
c) Compounding, transportation and storage
d) Compounding, transportation, storage and administration

A

C - Compounding, transportation and storage

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18
Q

Interferons fall in the follow ing category

a) Granulocyte colony-stimulating factors
b) Leukemia inhibitory factors
c) Stem cell factors
d) Interleukins
e) Cytokines

A

E - cytokines

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19
Q

Avonex®(IFN-b1a, Biogen Inc.) and Betaseron®(IFN-b1b, Berlex) are two different IFN products that

a) Come from the same cell type
b) Come from different cell type

A

A

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20
Q

Select a correct statement

a) The proteins in both Epogen®and Nupogen®are glycosylated
b) The protein in Epogen®is glycosylated, w hile the protein in Nupogen®is not
c) The protein in Nupogen®is glycosylated w hile the protein in Epogen®is not
d) Neither of proteins in Epogen®or Nupogen®are glycosylated
e) The aminoacid residue chains of both Epogen®and Nupogen®are too short to forthem be considered as proteins

A

B - The protein in Epogen®is glycosylated, w hile the protein in Nupogen®is not

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21
Q

Hemophilia A and B are associated w ith deficiencies in factors ___, respectively.

a) VI and VII
b) VII and VIII
c) VIII and IX
d) IX and X
e) VI and IX

A

C - VIII and IX

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22
Q

You are asked to dispense a new monoclonal antibody (mAb)-based drug,Mabtrema®. Due to modifications to the usual mAb structure, Mabtrema®is unable tobind to the neonatal Fc receptor (FcRn). Which of the follow ing properties w ould youexpect for Mabtrema?

a) the plasma half-life is longer than that of a typical mAb
b) the plasma half-life is shorter than that of a typical mAb
c) the plasma half-life is equal to that of a typical mAb
d) it binds Protein A with high affinity
e) it can be given orally

A

B - the plasma half-life is shorter than that of a typical mAb

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23
Q

Monoclonal antibodies (mAbs) are eliminated by all of the follow ing mechanismsEXCEPT:

a) proteolysis in the liver
b) metabolism by target cells
c) renal excretion of the unmetabolized parent drug
d) phagocytosis by the reticuloendothelial system (RES)
e) binding to antidrug antibodies (ADA) in the bloodstream

A

C -renal excretion of the unmetabolized parent drug

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24
Q

what amino acids are aromatic

A

phenylalanine
tryptophan
tyrosine

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25
Q

what amino acids are sulfur containing

A

cysteine

methionine

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26
Q

what amino acids are prone to deamidation

A

aspargine

glutamine

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27
Q

Glycosyl groups: will increase ______ and ______

A

stability and circulation time

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28
Q

Glycosylation vs PEGylation:

which one is natural and which one is synthetic

A

natural: glycosylation

PEGylation: synthetic

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29
Q

Glycosylation vs PEGylation:

both affect _____ and and help _______

A

affect PK

help reduce sorption

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30
Q

Biotech Stability Issues of Proteins:
Chemistry: (3 things)

Compounding: (3 things

A

Chem: denaturation, aggregation, deamidation

Compound: sorption, shear forces,foaming

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31
Q

Protein based meds come usually as _______ or ________

A

solutions or dry product for reconstitution

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32
Q

Sugars are used with biotech products why?

A

makes the drugs more stable

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33
Q

Hematopoeisis: related to?

A

production of blood cells

related to infection, allergic reaction, immune challenge, hemorrhage, inflammation, hypoxia

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34
Q

Hematopoeisis: begins in the _________ during early pregnancy

A

spleen/liver

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35
Q

During childhood, _____ is the primary hematopoetic site

A

bone marrow

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36
Q

Extramedular hematopoiesis (extremities) _________ with age

A

decreases

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37
Q

what does EPO stand for

A

erythropoietin

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38
Q

what does TPO stand for

A

thrombopoietin

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39
Q

what does G-CSF stand for

A

Granulocyte colony-stimulating factor

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40
Q

what does M-CSF stand for

A

Macrophage colony-stimulating factor

41
Q

what does GM-CSF stand for

A

Granulocyte-macrophage colony-stimulating factor

42
Q

what does IL stand for

A

Interleukin

43
Q

neutropenia = Decreased blood neutrophil count below _________

A

1,800 cells/mm3

44
Q

different causes of neutropenia?

A

chemotherapy, contaminant therapy, renal function

45
Q

Hemophilia A is deficient of ________

A

Factor VIII

46
Q

Hemophilia B is deficient of ______

A

Factor IX

47
Q

EPO vs Filgrastim:

which one is glycosylated

A

EPO

48
Q

IFN-a comes from ______

A

leukocytes

49
Q

IFN-j comes from ______

A

fibroblasts

50
Q

IFN (phi or psi?) weird symbol is from _____

A

activated t lymphocytes

51
Q

what was the first human protein demonstrated to increase survival of cancer patietns

A

interferon!

52
Q

what different effects do interferons have?

A

antiviral
antitumor
MS!

53
Q

Hormones started as coming from animal extracts - but where the cons?

A
  • contamination w/ other animal proteins
  • risk of immunological side effects
  • not all animal hormones have high homology w/ human counterparts
54
Q

what enzyme gets replaced in cystic fibrosis

A

DNAse

55
Q

what disease gets glucocerebrosidase?

A

Gauchers Disease

56
Q

_______ is a biologic produced by a living

system that has been genetically engineered

A

Biopharmaceutical

57
Q

USP:
Chapters > 1000 are _______
Chapters < 1000 are ______

A

> 1000: informational

< 1000: are enforcable

58
Q

Revised USP 797:

became effective in ______

A

2008

59
Q

797 Lecture:

______ are a major source of contamination

A

people

60
Q

797 Lecture:

Immediate Use CSPs — relation to 797?

A

they are exempt form 797 requirements!!

61
Q

797 Lecture:

examples of immediate use CSPs

A 
patient bedside
ambulance
ER
combat zone
code
62
Q

797 Lecture:

administration of immediate use CSPs must begin within ______ of start of preparation

A

1 hour

63
Q

T or F: you can store ampuls

A

falseee

64
Q

hazardous drugs is USP ____

A

800

65
Q

radiopharmaceuticals is USP _____

A

825

66
Q

1 fl oz = _____mLs

A

29.57 mL

67
Q

1 pint = ______mLs

A

473 mL

68
Q

1 gallon = _____mLs

A

3785

69
Q

2 pints = ____ quarts

A

1

70
Q

4 quarts = ____ gallon

A

1

71
Q

1 g = _____ gr

A

15.432

72
Q

1 gr = _____ mg

A

64.8

73
Q

1 kg = ____ lbs

A

2.2

74
Q

1 lb = _____ g

A

454

75
Q

1 in = ____ cm

A

2.54

76
Q

1 tsp = _____ mL

A

5 ml

77
Q

1 tbsp = ____ mL

A

15 mL

78
Q

how to find BSA?

A

square root of…

(height (in cm) x weight (in kg))/ 3600

79
Q

average BSA for an adult?

A

1.73 m^2

80
Q

units for BSA?

A

m^2

81
Q

units of percentage strength should always be what?

A

GRAMS and MILLILITERS!!! (by the 100!)

ex: 75 g / 100 mLs = 75% w/v

82
Q

units of ratio strength should always be what?

A

GRAMS and MILLILITERS!!!

83
Q

units of milligram percent should always be what?

A

mg and mL!!!

of mg’s per 100 mL’s of liquid

should be annotated as 5mg%

84
Q

what amino acid(s) is/are involved in disulfide exchange

A

cysteine

85
Q

what amino acid(s) is/are involved in beta elimination and racemization

A

Ser, Thr, Cys

86
Q

what amino acid(s) is/are involved in hydrolysis, racemization, and isomerization

A

Asp

87
Q

what amino acid(s) is/are involved in deamidation, racemization and isomerization

A

Asn, Gln

88
Q

monoclonal Abs naming:

  • mo-
  • xi-
  • zu-
  • mu-

each one goes with what type of antibody?

A

mo - murine/mouse
xi - chimeric
zu - humanized
mu - human

89
Q

what are some examples of protein stabilizers?

A

sucrose
trehalose
mannitol
sorbitol

90
Q

protein stabilizers are preferentially excluded from the _______

A

protein surface

91
Q

more excipients will ______ the temperature level of when the protein will degrade

A

will increase the temp

92
Q

______ prevent adsorption to the surface

A

surfactants

93
Q

interaction b/w proteins and ice:

In a frozen matrix, proteins interact with the surface of ice, __________ structure

A

loosening of the native

94
Q

An optimum freezing rate needs to be defined for each protein:
______ freezing rate with larger ice crystals (_____ surface area) would be preferable.

However, a slower rate can lead to a greater degree of macro cryoconcentration, as well as longer exposure to the cryoconcentrated and/or pH-altered medium, leading to ________

A

slower freezing rate

less surface area

leading to destabilization

95
Q

Thawing of Proteins:
Proteins may get sheared at ice – liquid interfaces and lose ______
Concentration gradients created during freezing can _______ the protein during thawing
______ thawing rates are usually preferred for protein stability

A

their activity;

can harm the protein

faster rates

96
Q

what is gliding force

A

how much force is needed to push the drug through a syringe.. (ex: humira/pre-filled syringe type things)

97
Q

TPN preparations are considered ___________ preparations according to USP<797>
.a) Low Risk
b) Medium Risk
c) High Risk

A

B - medium

98
Q

According to USP <797>, forLow Risk compounding, there should be not more than X commercially manufactured packages of sterile products and not more than Y entries into any one sterile container or package

X = #? and Y = #?

A

3;

2 entries

Fall 2018/P3 Year' (16 decks)

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