BYRN Exam 1 Flashcards

1
Q

Drug discovery

A

10,000 candidates, 1 drug molecule

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2
Q

Cardinal rules

A
  1. know what you have
  2. make the same thing every time ( controlled by specifications that are binding quality standards like methods and numbers)
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3
Q

United States Pharmacopeia (USP)

A

1820 established by physicians
1830 Rph join
National Formulary (NF) - published by APha, 1975 USP purchased NF
USP-NF is revised annually in hardcopy and online

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4
Q

Assay

A

Procedure used to test for potency

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5
Q

Monograph chart

A

tests for impurities

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6
Q

API

A

active pharmaceutical ingredient / active ingredient

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7
Q

IND

A

Investigational new drug, document to allow first in human trial
Ex - pure drug AB1234
needs component, quality, function, reference to standard
Ex - capsules: description, identification, content, degradation, dissolution

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8
Q

Excipients

A

substances in dosage form that may not have therapeutic use
wrong excipients can lead to death
excipients are controlled by USP

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9
Q

Universal tests for new drugs

A

description: state, color, identification, assay, impurities

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10
Q

specific tests for new drugs

A

physicochemical properties, particle size, polymorphic forms, tests for chirality, impurities, assay, identity, dissolution, disintegration, hardness, microbiol, water

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11
Q

New drug challenges

A

short time, broad dose range, minimal amounts of API, API w/ different attributes

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12
Q

New drug strategy

A

knowledge based decision making, prepare in small scale, determine performance often(assessing stability, animal pK, pKa for manufacturing.

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13
Q

Beta blockers

A

dischloroisoprotenol –> promethalol –> propanol

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14
Q

H2 antagonist

A

burimamide –> metiamide –> cimetidine

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15
Q

IND application

A

content, clinical protocol meetings, FDA review
clinical studies and control, dosage & terminology, treatment IND, withdrawal/termination drug
applying: content of NDA submission, product labeling, FDA review, phase 4 studies, adverse drug experience, annual reports

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16
Q

SNDA

A

supplemental new drug application

17
Q

ANDA

A

abbreviated new drug application, nonclinical lab studies may be omited, generic drug products, requires study about bioavailability

18
Q

other drug applications

A

animal drug application and medical devices

19
Q

Biologics license application (BLA)

A

vaccines and monoclonal antibodies

20
Q

ADME

A

absorption, distribution, metabolism, excretion

21
Q

preformulation

A

drug solubility, partition coefficient, drug must pass bio membrane (be lipophilic enough to be able to penetrate bio membrane)

22
Q

dissolution rate

A

speed at which substance dissolves related to size, partition coefficient, etc

23
Q

physical form

A

crystalline vs amorphous, particle size

24
Q

drug stability

A

physical + chemical, formulation, absorption, hydrolysis, heat

25
product formulation + trial materials
dosage forms, dosage strength, initial formulations, clinical supplies
26
clinical trials
phase 1: determine human pharmacology - 20-100 people, months, 67% completion rate phase 2: controlled chemical studies for effectiveness - up to several hundred, months-2 years, 45% completion rate phase 3: several hundred to thousands of patients in controlled and uncontrolled trials - 100s-1000s, 5-10% completion rate
27
crossover study design
giving subjects both drug and placebo and seeing the effects
28
Personal Requirements
Responsibility of quality control unit, employees, consultants
29
Building and facilities
structure, space, equipment will have thorough cleaning for safe and effective use
30
equipment
appropriate, suitably located, standard operating procedure
31
control of components
use written procedures
32
production and process control
written procedures, correct quality and quantity, any deviation must be recorded and justified
33
package labeling
expiration date, tamper evident packaging
34
holding and distribution
written procedures, stored and shipped w/ appropriate conditions
35
lab control
conformance to standards and specifications
36
reports and records
complete production, control, distribution records for at least 1 year
37
NECC FDA inspection
example - observed 83/321 vials w/ black matter, tarnished surfaces, used to handle mattresses. results - API were nonsterile, steam autoclave was not effective for cleaning surfaces, contaminated air.
38
ICH10 objectives
Achieve product realization, establishes state of control, gives us control, facilitates continuous improvements, cost, quality, strength.
39
monograph info
assay, definition, chart, impurities, solubility requirements