Exam 2

Question 1

Cmax of Oral vs IV drugs

Answer 1

Oral drugs have lower Cmax than IV drugs at the same dose

Question 2

Lag time

Answer 2

delay in absorption seen in some drugs

Question 3

What can contribute to lag time?

Answer 3

Drug formulation

Physiologic factors such as gastric emptying time

Question 4

How long can lag time be?

Answer 4

minutes to hours

Question 5

Enteric coating effect on lag time?

Answer 5

increase, causes long lag times

Question 6

Onset time

Answer 6

time required for pharmacologic effects to start

Depends on how fast plasma conc reach minimum effective conc

Question 7

“Flip Flop”

Answer 7

occurs when absorption is inherently slow

formation is controlled release type

Elimination half-life is short

Question 8

Flip flop will cause drug to exhibit….

Answer 8

absorption rate limited elimination

Question 9

Flip flop is when

Answer 9

linear segment of oral curve represents absorption phase, instead of elimination

Question 10

How to ID Flip Flop?

Answer 10

Using IV data

Using data from different dosage forms admin via the same route

Using data from different routes admin

Question 11

When half-life for oral and IV data are very similar, then…

Answer 11

terminal oral half life is related to the elimination

Question 12

When IV half-life is shorter than that of oral, then….

Answer 12

terminal oral half-life is related to absorption process

Question 13

Solutions vs Tablets?

Answer 13

Solutions exhibit faster absorption and shorter half lives

Tablets show slower absorption and longer half-lives

Question 14

Half life when drug Admin via IM and Oral route?

Answer 14

Terminal Half-lives = same

Question 15

Absorption half-life and elimination half-life when admin via 2 different routes?

Answer 15

Absorption half-life will be different

Elimination half-life will be the same

Question 16

How does K effect Tmax?

Answer 16

Larger K/Ka will result in shorter Tmax

inversely related

Question 17

What’s required for new drug to be made?

Answer 17

Drug discovery, formulation, lab development, animal studies, clinical studies

IND,NDA, IRB

Long process

Question 18

What’s required for Generic drug to be made?

Answer 18

ANDA

Eval of BE studies for approval in 1984 (Waxman-Hatch Act, Drug price competition and patent term restoration act)

Question 19

Reference Listed Drug

Answer 19

ID by FDA as th drug product on which an applications relies when seeking approval of ADNA

Usually the brand name drug that has full NDA

Question 20

Abbreviated New Drug Application

Answer 20

ANDA

must be filed and approved for generic drug

Generic manufacturer is not required to perform clinical efficacy studies or nonclinical toxicology studies

Question 21

Drug Substance

Answer 21

the active pharmaceutical ingredient

Question 22

Drug product

Answer 22

the finished pill, tab, capsule, solution etc

Question 23

Pharmaceutical Alternatives

Answer 23

Products that contain same therapeutic moiety but as different salts, esters, or complexes

Ex.

XR and IR dosage forms

Question 24

Pharmaceutical Equivalents

Answer 24

Products in identical dosage forms that contain the same active ingredients (same Salt/Ester), same dosage form, use same route of admin, and identical in strength or conc

Question 25

How can pharmaceutical equivalents differ?

Answer 25

shape, scoring configuration, release mechanisms, labeling, packaging

Question 26

Bioequivalent Drug products

Answer 26

Rate and extent of absorption do not show significant difference when admin at same molar dose of the therapeutic moiety

Question 27

Bioequivalence Requirement

Answer 27

imposed by FDA for in vitro/in vivo testing of specified drug products which must be satisfied as a condition of marketing

Question 28

Pharmaceutical Substitution

Answer 28

dispensing pharmaceutical alternative for prescribed drug product Ex. ampicillin suspension in place of capsules

Question 29

Generic Substitution

Answer 29

dispensing different brand or unhanded drug in place of prescribed drug product Ex. Ibuprofen in place of Motrin

Question 30

Therapeutic Alternatives

Answer 30

products containing different active ingredient that are indicated for the same therapeutic or clinical objectives

Question 31

Therapeutic Equivalents

Answer 31

products considers only if they're pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when admin to patients

Question 32

2 Formulations are bioequivalent when AUC and Max are...

Answer 32

within 80 - 125% of those for reference formulation

Question 33

Orange book

Answer 33

FDA published ``` A = therapeutically equivalent B = not therapeutically equivalent ```

Question 34

Common study in Bioequivalence study?

Answer 34

Crossover design

Question 35

3 studies required for solids dosage forms

Answer 35

Fasting study Food interaction study Multiple Dose study

Question 36

Bio-waivers

Answer 36

using in vitro dissolution profile instead of in-vivo bioavailability

Question 37

When are Bio-waivers used?

Answer 37

When product is same dosage form but in different strengths and is proportionally similar in active and inactive ingredients

Question 38

Bio-waiver can be granted for different strengths of a drug product when....

Answer 38

1. The drug product is in the same dosage form, but in a different strength 2. This different strength is proportionally similar in its active and inactive ingredients to the strength of the product for which the same manufacturer has conducted an appropriate in vivo study 3. The new strength meets an appropriate in vitro dissolution test.

Question 39

What is a biosimilar product?

Answer 39

1. Copy of a renege biological product that shares same primary amino acid sequence with that of reference 2. Changing order of amino acids creates different primary structure 3. Differences in critical quality attributes are close enough to achieve a designation of similarity following an assessment of safety and efficacy

Question 40

Biosimilars vs Generics

Answer 40

Generics = pretty much identical (2 green apples) Biosimilars = Similar (Green vs Red apple)

Question 41

IV infusion Advantages

Answer 41

1. Can deliver exact amount of drug into body to achieve and maintain a certain conc 2. Unlike multiple dosing, IV infusion circumvents ups/downs of drugs plasma levels 3. Allows co-admin of drugs with IV fluids 4. Drug admin can be initiated and terminated as needed

Question 42

IV infusion disadvantages

Answer 42

1. Requires hospitalization and specialized devices at home | 2. Expensive and inconvenient

Question 43

What order process is IV infusion admin?

Answer 43

Zero order

Question 44

What order process is IV infusion elimination?

Answer 44

First order

Question 45

Relationship of Css, infusion-rate, and Clearance?

Answer 45

When the infusion rate is doubled, Css will be doubled. When drug clearance decreases, Css would increase

Question 46

Time to reach Css depends on....

Answer 46

only alf-life of drugs, not on the dose