BYRN Exam 1

Question 1

Drug discovery

Answer 1

10,000 candidates, 1 drug molecule

Question 2

Cardinal rules

Answer 2

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

Question 3

United States Pharmacopeia (USP)

Answer 3

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

Question 4

Assay

Answer 4

Procedure used to test for potency

Question 5

Monograph chart

Answer 5

tests for impurities

Question 6

API

Answer 6

active pharmaceutical ingredient / active ingredient

Question 7

IND

Answer 7

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

Question 8

Excipients

Answer 8

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

Question 9

Universal tests for new drugs

Answer 9

description: state, color, identification, assay, impurities

Question 10

specific tests for new drugs

Answer 10

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

Question 11

New drug challenges

Answer 11

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

Question 12

New drug strategy

Answer 12

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

Question 13

Beta blockers

Answer 13

dischloroisoprotenol –> promethalol –> propanol

Question 14

H2 antagonist

Answer 14

burimamide –> metiamide –> cimetidine

Question 15

IND application

Answer 15

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

Question 16

SNDA

Answer 16

supplemental new drug application

Question 17

ANDA

Answer 17

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

Question 18

other drug applications

Answer 18

animal drug application and medical devices

Question 19

Biologics license application (BLA)

Answer 19

vaccines and monoclonal antibodies

Question 20

ADME

Answer 20

absorption, distribution, metabolism, excretion

Question 21

preformulation

Answer 21

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

Question 22

dissolution rate

Answer 22

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

Question 23

physical form

Answer 23

crystalline vs amorphous, particle size

Question 24

drug stability

Answer 24

physical + chemical, formulation, absorption, hydrolysis, heat

Question 25

product formulation + trial materials

Answer 25

dosage forms, dosage strength, initial formulations, clinical supplies

Question 26

clinical trials

Answer 26

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

Question 27

crossover study design

Answer 27

giving subjects both drug and placebo and seeing the effects

Question 28

Personal Requirements

Answer 28

Responsibility of quality control unit, employees, consultants

Question 29

Building and facilities

Answer 29

structure, space, equipment will have thorough cleaning for safe and effective use

Question 30

equipment

Answer 30

appropriate, suitably located, standard operating procedure

Question 31

control of components

Answer 31

use written procedures

Question 32

production and process control

Answer 32

written procedures, correct quality and quantity, any deviation must be recorded and justified

Question 33

package labeling

Answer 33

expiration date, tamper evident packaging

Question 34

holding and distribution

Answer 34

written procedures, stored and shipped w/ appropriate conditions

Question 35

lab control

Answer 35

conformance to standards and specifications

Question 36

reports and records

Answer 36

complete production, control, distribution records for at least 1 year

Question 37

NECC FDA inspection

Answer 37

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.

Question 38

ICH10 objectives

Answer 38

Achieve product realization, establishes state of control, gives us control, facilitates continuous improvements, cost, quality, strength.

Question 39

monograph info

Answer 39

assay, definition, chart, impurities, solubility requirements