Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

PVC Product > PVC Definitions > Flashcards

PVC Definitions Flashcards

1
Q

What is Investigator Initiated Study (IIS):

A

A clinical study where we provides medicinal product and/or financial, or material support to an external Sponsor (i.e. researchers, collaborative groups, academic institutions) will be defined as a supported study

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

As a standing member of the Study Review Team (SRT), the PV Clinical Responsible is accountable for:

A
  1. Study Classification (i.e. Interventional/Non-Interventional)
  2. Review of protocol safety language / Safety Data Exchange Agreement (SDEA)
  3. Inclusion of Adverse Event of Special Interest (AESIs), as applicable
  4. Post Authorization Safety Study (PASS) assessment
  5. Oversight of safety reporting and CTV activities
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

What is CSM?

A

clinical study manager

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

What is PASS?

A

post-authorization safety study -study that is carried out after a medicine has been authorized to obtain further information on a medicine’s safety, or to measure the effectiveness of risk-management measures.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What is RSI?

A

reference safety information The RSI is used to determine the expectedness of a Serious Adverse Reaction (SAR). If the serious event is considered related to the investigational medicinal product (IMP) and the serious reaction is not included in the RSI, this becomes a SUSAR (Suspected Unexpected Serious Adverse Reaction) and has to be reported to the MHRA. Inclusion of a SAR as an expected event in the RSI needs to be accompanied by an assessment of the benefit-risk profile of the IMP and ongoing trials. The competent authority will then decide whether the list of expected reactions and associated risk minimization measures are acceptable.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

What is IMP?

A

investigational medical product

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What is SUSAR?

A

Suspected Unexpected Serious Adverse Reaction is the term used to refer to an adverse event that occurs in a clinical trial subject, which is assessed by the sponsor and or study investigator as being unexpected, serious and as having a reasonable possibility of a causal relationship with the study drug.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What is NDA

A

New drug application

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What is IND?

A

Investigational New Drug submissions to FDA for drugs that are starting a new indication or investigation-

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Name governing bodies

A

FDA, NIH, EMA, MHRA, WHO, PhrMA

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What is IRB?

A

Investigational Review Board

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

What does IRB do?

A

The Institutional Review Board (IRB) responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants. The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, exempt, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What is sponsored study?

A

Managed (or Sponsored/Roche initiated)- Roche itself raises the scientific question to be answered, Roche is responsible for the conduct of the trial;
* Interventional clinical trials
* Real world evidence (RWE) activities

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

What is supported study?

A

Funded ( or Supported/Investigator initiated): Roche provides money and/or free drugs to an investigator, or group of investigators, to help them conduct their own research

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What is a mAB? monocolonial antibody?

A

man-made proteins that act like human antibodies in the immune system.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Does timing of covid vaccine and Ocrevus treatment matter?

A

Ocrevus may impact the effectiveness of non-live vaccines which is why vaccine should be given at least 2 weeks prior to first infusion

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

How do vaccines work?

A

Vaccines contain weakened or inactive parts of a particular organism (antigen) that triggers an immune response within the body.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Black box warning

A

Black box warnings—are required by (FDA) when a medication could cause illness or injury that may result in hospitalization or death. They may be part of the labeling when a drug is first marketed, or they may be added after information emerges from wider use of the drug or additional clinical trial data

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Half life of Ocrevus

A

33 weeks

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

MOA of Ocrevus

A

MOA: Ocrelizumab selectively targets the CD20-positive B-cells by binding to the surface proteins of the cells and protecting the nerve cells from mediated damage

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

Ocrevus indication:

A
  • Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
  • Primary progressive MS
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Prior to initiation of ocrevus you must

A

hep B virus and quantitative serious immunoglobulin screen; pre-medication with methylpred; antihistamine prior to each infusion

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

Dose of ocrevus

A

300mg IV infusion; 2 weeks later 300mg then 600mg every 6 months

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

Contraindication of Ocrevus

A

active hep B virus infection; h/o life threatening infusion reaction

25
Q

Warning of Ocrevus

A

infusion rxn. Infections, do not give vaccinations with live vaccine (4 weeks prior to initiation); 2 weeks with inactivated; reductions of immunoglobulins, Malignancies (including breast cancer)
Immune mediated colitis- monitor for Diarrhea, GI symptoms; PML

26
Q

s/s of PML:

A

(progressive multifocal leukoencephalopathy) s/s: clumsiness; progressive weakness; and visual, speech, and sometimes personality changes

27
Q

common s/e of ocrevus

A

Common s/e: upper respiratory infection; infusion reaction

28
Q

MOA of Actemra

A

novel monoclonal antibody that competitively inhibits the binding of interleukin-6 (IL-6) to its receptor (IL-6R). Inhibiting the entire receptor complex prevents IL-6 signal transduction to inflammatory mediators that summon B and T cells.

29
Q

Indication of Cotellic (tablet)

A

indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.

30
Q

MOA of Cotellic

A

MOA: reversible inhibitor of mitogen-activated protein kinase (MAPK)/extracellular signal regulated kinase 1 (MEK1) and MEK2.

31
Q

half life of Cotellic

A

44 hours

32
Q

Erivedge: indication

A

Erivedge: hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation.

33
Q

Erivedge: MOA

A

MOA: Vismodegib binds to and inhibits Smoothened, a transmembrane protein involved in Hedgehog signal transduction.

34
Q

Erivedge half life

A

Half-life: 4 days after continuous once-daily dosing and 12 days after a single dose.

35
Q

Tecentriq MOA

A

Tecentriq: atezolizumab- programmed death-ligand 1 (PD-L1) blocking antibody; blocking PD-L1 activity resulted in decreased tumor growth.

36
Q

half life of Tecentriq

A

27 days

37
Q

Tecentriq indications

A

urothelial caricinoma; non-small cell lung cancer (adjuvant treatment with platinum based chemo (cisplatin, carboplatin, and oxaliplatin); the first-line treatment of adult patients with metastatic NSCLC; small cell lung cancer; hepatocellular carcinoma, melanoma

38
Q

half life of tecentriq

A

27 days

39
Q

Xolair MOA

A

Omalizumab binds free IgE in the serum, forming trimers and hexamers. IgE bound to drug cannot bind its receptor on mast cells and basophils. Omalizumab does not bind IgE that is As a result of the binding of free IgE, the number of IgE receptors on the surface of mast cells and basophils declines over time, which is believed to be a critical component of the clinical effect of the drug.

40
Q

Xolair half life

A

26 days

41
Q

Xolair indications:

A

asthma, nasal polyps, chronic spontaneous urticaria

42
Q

Mechanism of action of alteplase

A

recombinant tissue plasminogen activator (rt-PA) ; used as a thrombolytic agent; cleaves plasminogen to form plasmin, an enzyme involved in the degradation of fibrin clots.

43
Q

how is alteplase cleared and half life?

A

primarily cleared by the liver with an initial half-life of fewer than 5 minutes and a terminal half-life of 72 minutes.

44
Q

indication of alteplase?

A

Acute Ischemic stroke, Acute MI, Acute massive PE

45
Q

dose of alteplase for stroke??

A

0.9 mg/kg (not to exceed 90mg total dose); 10% is given as a bolus over a minute; then infused over 60 minutes

46
Q

how is dose of alteplase different for PE and MI

A

100mg max dose

47
Q

CI of alteplase

A

Active internal bleeding.
* Recent intracranial or intraspinal surgery or serious head trauma.
* Intracranial conditions that may increase the risk of bleeding.
* Bleeding diathesis.
* Current severe uncontrolled hypertension.
* Current intracranial hemorrhage.
* Subarachnoid hemorrhage.

48
Q

Drug interactions of alteplase

A

Anticoagulants and drugs that inhibit platelet function increase the risk of
bleeding when administered with Activase therapy.
Concomitant angiotensin-converting enzyme inhibitors may increase the risk
of angioedema.

49
Q

initiate treatment of alteplase within—-

A

3 hours after symptom onset

50
Q

warnings of alteplase

A

bleeding; monitor CBC with differentials

51
Q

AEs of alteplase

A

Bleeding
* Hypersensitivity
* Thromboembolism
* Cholesterol Embolization

52
Q

what do to before alteplase

A

CT scan to rule out intracranial hemorrhage

53
Q

alteplase 2mg

A

for central line catheter patency; not systemically absorbed

54
Q

clinical trial: preclinical

A

testing drug on non-human subjects to gather efficacy, toxicity, and PK info

55
Q

clinical trial: 1

A

PK testing (bioavailability and half life)

56
Q

clinical trial: 2

A

dose ranging on healthy volunteers for safety

57
Q

clinical trial: 3

A

testing on participants to assess efficacy effectiveness and safety

58
Q

clinical trial: 4

A

post marketing surveillance in public

PVC Product (1 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions