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ceutics > packet 1 - rocca > Flashcards

packet 1 - rocca Flashcards

0
Q

how much time does it take to develop drug

A

10-15 years

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1
Q

percent of generic drugs used in 2000 vs. 2012

A

49% 2000

84% in 2012

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2
Q

cost of drug development in 2000 compared to 70s 80s 90s

A

2000 - 1.2 billion
90s- 800 mil
80s- 318 mil
70s- 140 mil

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3
Q

what are the steps in the research and development process (4 steps)

A
  1. drug discovery and pre-clinicals
  2. clinicals - 3 phases
  3. FDA review and scale-up manufacturing
  4. post marketing, monitoring, and research
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4
Q

length of time in each step of the research and drug development process

A
  1. drug discovery and pre-clinicals: 3-6
  2. clinicals: 6-7
  3. FDA review and scale-up manufacturing: 1/2 - 2 years
  4. post marketing, monitoring, and research: indefinite
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5
Q

between 2000-2007 what was the industry with the highest expenditures and how much do they spend on a yearly basis

A

biopharmaceuticals

50 million each year

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6
Q

2 key facts of the pharmaceutical industry

A
  1. most research-intense industry

2. as much as 5 times more in research and development relative to sales

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7
Q

NDA

A

new drug application

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8
Q

FDA

A

food drug administration

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9
Q

IND

A

investigation new drug

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10
Q

value of medicine as it pertains to life expectancy: what significant changes have been seen

A

50-60% of life expectancy increase has been due to meds
cancer- 3 year increase, 83% attributed to new treatment and meds
cardiovascular disease- death rate fell by 33%
hiv/aids- death rate has dropped more than 85%

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11
Q

3 main acts of drug regulation and control

A

1906 federal food and drug act
1938 federal food, drug, and cosmetic act
1962 kefauver (harris drug amendments)

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12
Q

1906 federal food and drug act

A

benefit was not regulated

strength, purity, quality

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13
Q

1938 federal food, drug, cosmetic act

A

increased safety
FDA
NDA

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14
Q

1962 kefauver (harris drug act)

A

efficacy

IND must be filed

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15
Q

code of federal regulation CFR

A

codification of general and permanent rules published in the federal register by executive departments and agencies of the federal government

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16
Q

what are the number of titles in the CFR and how is it divided and what does it represent

A

50 titles
divided into branches - bears name of issuing company
represents areas that are subject to fed regulation

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17
Q

title 21 of the CFR

A

consists of 8 volumes containing regulation by federal food drug and cosmetic act and other statues administered by FDA

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18
Q

title 21 part 300-314

A

requires new drugs to be approved by FDA before legally introduced
applies to drug manufactured in US and imported

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19
Q

the FDA will approve NDA only if it demonstrates evidence of:

A

safety

effectiveness

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20
Q

condensed steps in the development of new product

A

identify molecular entity
pharmacological activity
small scale lab manufacturing

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21
Q

small scale lab manufacturing assess what 3 things

A

toxicity
research
preformulation- identify its stability

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22
Q

What are the federal approval requirements no what do they preserve

A

Adequate manufacturing and control
Processing of drug
Packaging of drug
Preserves: strength, safety, identity, purity, quality

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23
Q

Product goals of drug

A 
Safety
Strength 
Identity
Purity
Quality
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24
Q

Product is free of unwanted side effects when used appropriately by patient

A

Safety

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25
Q

product exactly matches the labeling and related documents

A

identity

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26
Q

product has correct concentration, potency, or therapeutic activity of active ingredient

A

strength

27
Q

product is free of contamination

A

purity

28
Q

quality

A

product meets all standards, expectations; performs as claimed
product made consistently

29
Q

important factor that must be present in order to obtain FDA approval is

A

CMC chemistry manufacturing control

30
Q

what happens if you do not have chemistry manufacturing and control

A

drug is recalled — can be do to contamination, yeast etc

31
Q

disciplines of drug discoveries and design

A 
chemist
biologist/molecular biologist
pharmacologist
toxicologist
staticians
physicians, pharmacists
pharmaceutical engineers, scientists, etc
32
Q

a clinical study cannot be conducted without:

A

optimal dosage form

33
Q

drug discovery resources

A

natural
semi-synthetic
synthetic

34
Q

drug resource examples

A

vinca rosea - yielded vinblastine and vincristine
pacific yew tree extract - paclitaxel
animal endocrine gland - thyroid extract
urine of pregnant mares - estrogen

35
Q

many drugs, vitamins, biotechnology and many other substances produced this way:

A

fermentation

36
Q

methods of drug discovery (6)

A 
random screens
non-random screens
molecular modifications
mechanism-based drug design
molecular graphics 
pharmcogenomics
p
37
Q

types of non-random screens

A

bio-assay
disease specific animal models
high throughput screenings

38
Q

molecular modications

A

proves efficacy by attaching a functional group

39
Q

mechanism based drug design

A

drugs designed to interfere/inhibit a known or suspect pathway of mechanism of a disease process

40
Q

molecular graphics

A

the use of computers to represent and manipulate the structure of a drug molecule to fit the simulated molecular structure of the receptor site

41
Q

pharmacogenetics

A

refers to the genetics differences which can affect the individual responses to drug, both in terms of therapeutic effect and adverse effects

42
Q

pharmacology

A

the study of drugs

43
Q

genomics

A

the study of genes and their functions

44
Q

pharmacology + genomics =

A

pharmacogenetics: the study of how your genes affect your response to drugs

45
Q

pharmacogenomics benefits (4)

A

development of tailored medicine
more accurate method of determining appropriate drug dosages
improvement of drug discovery an approval process
better vaccines

46
Q

micro-array monitors change in dna sequencing

if so, can be evaluated for pathotoxins T/F

A

true

47
Q

what is a sandwich assay used for

A

to identify infectious agents responsible for illnesses

48
Q

steps in protein array (sandwich array)

A
  1. blood sample placed on array/chip
  2. multiple Ab assigned to each well
  3. Ab will bind to specific protein from one organism (represent disease causing agent)
  4. apply fluorescent Ab (attaches to 2nd site on protein)—forms sandwich — scanned to determine organism present
49
Q

new drug definition

A

drug not recognized by experts

qualify as being safe and effective for its use

50
Q

FDA definition of new drug (5)

A 
new combination of two or more drugs
new use for old drug
new dosage schedule and regimen
new route of admin
new dosage form
51
Q

drug nomenclature - 4 steps

A
  1. empirical formula
  2. systemic name - more descriptive than emperical
  3. nonproprietary name (generic)- only if drug is promising
  4. code numbers United States adopted names council (USAN council) - assigns name to nonproprietary names
52
Q

3 areas that we look at for pre-clinical development

A
  1. pharmacology
  2. drug metabolism
  3. toxicology
53
Q

chemical and physical properties of a compound are evaluated to provide an _______ and _______ pharmaceutical products.

A

effective and stable

54
Q

pharmaceutics and formulations involves: (chemistry manufacturing control) (3)
in which section of the CFR is it found

A

physical and chemical properties
initial formulations - clinical trails
pilot plant-scale up - large scale manufacturing
CFR title 21 part 300

55
Q

pharmaceutical industry accounts for the majority of drug delivery system in global market. drug delivery technology accounts for ___%

A

10

56
Q

the total size of pharmaceutical products is ____. drug delivery technology is ___ billion

A

800 billion

90 billion

57
Q

____ types of drug delivery will remain the largest drug delivery category while parenteral, inhalation, and implantable system grow the fastest.

A

oral

58
Q

investigational new drug

what happens if approved

A

program by which pharmaceutical companies obtain permission to ship experimental drugs across state lines to clinical investigators before a marketing app has been approved. If cleared by the FDA, the drug candidate will enter phase one of clinical trials

59
Q

an investigation new drug (IND) is required for a clinical study if it is intended to support a: (4)

A

new indication
change in route of admin or dosage level
change in approved patient population or population at greater risk
significant change in the promotion of the drug

60
Q 
information gathered by IND (8)
#SCRODLE
A
  • SAFETY evaluation -NUMBER of patients
  • any CLINICAL data - estimated LENGTH of treatment
  • DRUG identification and manufacturing instructions
  • detailed OUTLINE of proposed study
  • ROUTE of administration
  • ENVIRONMENTAL impact statement
61
Q

multiple areas of drug approval process

A 
preclinical 
IND
phases I, II, III
NDA
IV
62
Q

timeline for drug development (include phases and time frames)

A

PRECLINICAL RESEARCH- discovery and early screening, large scale synthesis, animal testing, takes 5 years
CLINICAL STUDIES: phase I take 1 1/2 year, phase II takes 2 yrs, phase III takes 3 1/2 yrs (total of 7 years)
REVIEW OF FDA - 1 1/2 year
POST MARKETING SURVEILLANCE- ongoing

63
Q

what occurs in pre-clinical trials

A

discovery and early screening
large scale synthesis
animal testing
takes 5 years

64
Q

what occurs in clinical study stage and phases involved

A

file IND
take 7 years
3 phase:
Phase I - using healthy patient, use small dose, look for absorption response, takes 1 1/5 years
Phase II- recruit sick indv. determine actual dose, called dose response study because dose can be identified, need to make sure you have right formulation before entering phase III, 2 years
Phase III- efficacy study, longest phase bc you need indv with therapeutic need, all data is collected in this phase, takes 3 1/2 years

65
Q

phase that is called dose response study

A

phase II

ceutics (2 decks)

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