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PHRM 828: Dosage Forms > DOSAGE I: Exam 1 > Flashcards

DOSAGE I: Exam 1 Flashcards

1
Q

Who are the subjects of preclinical trials?

A

Animals

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2
Q

Who are the subjects of clinical trials?

A

Humans

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3
Q

What are the cardinal rules of dosage forms?

A
  1. Know what you have
  2. Make the same thing every time

(controlled by specifications -> binding quality standards)

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4
Q

What are the universal tests for New Drug Products?

A
  1. Description (only physical test -> appearance of drug)
  2. Identification (HPLC)
  3. Assay (test of potency/strength)
  4. Impurities
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5
Q

What are the challenges to drug discovery/design?

A
  1. Short time line
  2. Broad dose range (can’t be too close to fatal range)
  3. Minimal amounts of API
  4. API with different attributes
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6
Q

What is an abbreviated new drug application (NDA) used for?

A

Generic drugs

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7
Q

What is a biologics license application used for?

A

Vaccines + monoclonal antibodies

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8
Q

What is ADMET?

A

A = Absorption
D = Distribution
M = Metabolism
E = Excretion
T = Toxicity

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9
Q

What are the pre-formulation studies/tests?

A
  1. drug solubility
  2. partition coefficient
    -> how much of the drug gets absorbed
  3. dissolution rate
  4. physical form
  5. stability
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10
Q

What happens during Phase I of clinical trials?

A

Determine human pharmacology of the drug structure:
-activity relationships
-side effects with increasing doses
-evidence of effectiveness

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11
Q

What happens during Phase II of clinical trials?

A
  1. dose selection
  2. studies for effectiveness in patients with the condition
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12
Q

What happens during Phase III of clinical trials?

A

Hundreds to thousands of patients in controlled and uncontrolled trials

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13
Q

Volume/Part in Code of Federal Regulations (CFR) of General Provisions

A

Volume 21, Part 211

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14
Q

When was the NECC FDA inspection?

A

October 2nd, 2012

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15
Q

What did the FDA find in the 2012 NECC inspection?

A
  1. 83/321 vials contained a greenish-black foreign matter
  2. tarnished discoloration on surfaces of autoclave
  3. airborne particles from recycling facility only 100ft away from NECC
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16
Q

Define “reproducibility” in terms of drug design

A
  1. each dosage form contains between the same amount of drug
  2. drug has the same performance in the body
17
Q

What is Cmax?

A

Max concentration of drug in plasma / how much is in the system

18
Q

What is Tmax?

A

How much time it took to reach Cmax

19
Q

What comprises the disposition phase (relating to ADME)?

A

Distribution, Metabolism, Excretion

20
Q

What are the Factors Governing Drug Performance in the Clinic?

A
  1. Physicochemical properties of the API (i.e. solubility)
  2. Physicochemical properties and the composition of the formulation
  3. Physiological barriers that influence the targeted bioavailability of the drug
21
Q

What are excipients?

A

An PHARMACOLOGICALLY inert (but otherwise active) substance that forms a vehicle for a drug

22
Q

What are some common excipients?

A
  1. Cellulose based
  2. Sugars (i.e. sucrose, mannitol)
  3. Starch
  4. Synthetic polymers
  5. Magnesium stearate
23
Q

Poor absorption or permeation is likely when (Lipinski’s rules):

A
  1. More than 5 H-bond donors
  2. More than 10 H-bond acceptors
  3. MW > 500
  4. MlogP > 4.15
  5. ClogP > 5
24
Q

What is the Partition Coefficient?

A

Ratio of concentrations in two immiscible solvents (i.e. octanol and water)

25
Q

Define “druggable protein”

A

Proteins that can bind drug-like compounds with binding affinity below 10 mM (inferred that compound can functionally modulate the protein)

PHRM 828: Dosage Forms (5 decks)

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