Pharmaceutics part B

Question 1

define drug

Answer 1

agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease in human or other animals

Question 2

sources of drugs

Answer 2

chemical synthesis

natural sources - plants, animals, humans

Question 3

3 chemical classification of medications

Answer 3

inorganic
organic
biological

Question 4

define dosage form

Answer 4

any physical form that consists of both active ingredient and pharmaceutical excipients
usually single dose of medication

Question 5

6 reasons to make every drug compound into appropriate dosage forms

Answer 5

1. prevent active ingredients from degradation
2. conceal unpleasant flavor, taste, odor
3. facilitate mass production
4. use accurate dose of active ingredients
5. provide various product choices
6. enhance therapeutic outcome and compliance

Question 6

what is the major goal of drug delivery

Answer 6

obtain highest drug effects in the simplest admin way

Question 7

describe the new chemical entity stage (1)

Answer 7

the finding of a compound as a potential drug candidate including chemical synthesis, extraction, separation and purification

Question 8

describe the preclinical study stage (2)

Answer 8

preliminary investigation of the suitability of NCE as a therapeutic agent
early stage: physical, chemical, pharmacological, toxicological evaluations and in vivo behaviours
later stage: long term toxicity, formulation, preparation for drug launch

Question 9

describe investigation new drug application phase (3)

Answer 9

submission of basic info of a new chemical compound for review by health authority
safety major concern
clinical studies in human subjects can commence only after approval of IND application

Question 10

describe clinical trials (4)

Answer 10

phase 1 - drug safety in 20-100subjects
phase 2 - drug efficacy in 100 subjects
phase 3 - drug efficacy and dose evaluation in 1000s subjects

Question 11

describe new drug application stage (5)

Answer 11

submission of complete info of a chemical entity for review by the health authority

Question 12

describe post marketing stage (6)

Answer 12

review of any possibility after product marketing for further improvement or modifications

Question 13

4 biological stages in vivo

Answer 13

ADME

Question 14

defien bioavailability

Answer 14

rate and extent of an active ingredient from a formulation to the site of action
used to evaluate effectiveness ofdosage form

Question 15

define bioequivalence

Answer 15

comparison of bioavailability in diff formulation products or batches of the same activ eingredient

Question 16

what may be the cause of different bioequivalence between different companies

Answer 16

manufacturing proceses
different excipients used
different quality control measure

Question 17

how is most data for calculating the correct dose obtained

Answer 17

animal studies that are extrapolated into human doses

Question 18

how do computers help speed up drug development

Answer 18

can simulate and predict experiments

may be able to predict in vivo drug behaviours

Question 19

what are the 5 things we want in drug delivery

Answer 19

most effective 
appropriate form 
convenient application 
acceptable approach 
economic production

Question 20

what does pharmaceutics invole research and development of in pharmaceutical dosage forms

Answer 20

formulation
manufacture
stability
effectiveness

Question 21

how long does it take to make a drug

Answer 21

10-15 years

Question 22

what do you study in drugs in vitro

Answer 22

physical/analytical chemistry

solubility, stability, compatibility, quality control, packaging, premarketing evaluation

Question 23

what is the therapeutic outcome dependent upon

Answer 23

adme
pk parameters
dose
dosing frequency 
patient conditions

Question 24

why some drugs need fast onset of actions while some do not

Answer 24

to meet different therapeutic requirements

Question 25

why medications come in variable forms

Answer 25

to accomodate different therapeutic outcomes

Question 26

why oral dosage forms are the most of all products

Answer 26

most acceptable and concenient way of drug admin

Question 27

how can future development save costs

Answer 27

new manufacturing excipients/techniques
more generic products
more product choices