Pharmaceutics 701 Exam 1

Front 1

Supplemental New Drug Application (SNDA)

Back 1

-for requesting change to:
packaging, labeling, or formulation/route of admin

Front 2

New Drug Application (NDA)

Back 2

-filed after Phase I-III completed
-must prove safety & effectiveness

Front 3

Investigational New Drug Application (IND)

Back 3

-must be filed b/f drug given to humans/ clinical trials start
-main purpose to protect right/safety of subjects
-must have sound protocol

Front 4

Abbreviated New Drug App (ANDA)

Back 4

-for generics: don't need studies; just needs to show bioequivalence
-filed after patent expiration

Front 5

Treatment IND

Back 5

-allows pts w/ life-threatening disease to take drug even while it's still in clinical trials

Front 6

Describe elements of clinical protocol

Back 6

-purpose/objectives
-study design
-inclusn/xclusn criteria for subject
-dosing plan
-pt monitoring
-locatns
-IRB approval

Front 7

Phase I

Back 7

-20~40 HEALTHY ppl
-assess safety

Front 8

Phase II

Back 8

-200~400 pts (have disease)
-assess effectiveness, pharmacokinetics, safety
-refine formulatn

Front 9

Phase III

Back 9

-2k ~ 4k pts.
-assess overall risk:benefit profile
-additnl drug indicatns monitored

Front 10

Phase 4

Back 10

post-market surveillance

Front 11

Differentiate b/w manufacturing & compounding

Back 11

-manufacturing- large-scale productn of drugs
-compounding- preparing drug from bulk for resale

Front 12

GCP (good compounding practice) facilities

Back 12

-lighting
-clean
-separate sterile vs. nonsterile
-washing facilities

Front 13

GCP personnel

Back 13

pharmacist:
-inspectn/approval
-record review

Front 14

GCP equipment

Back 14

mortar/pestle, slab/spatula, balances

Front 15

GCP ingredients

Back 15

-USP-NF quality
-proper storage

Front 16

GCP compounding process

Back 16

-yield, physical characs, labeling/packaging, documentatn, pt counseling

Front 17

GCP Labeling

Back 17

-pharmacy no., xpir date, GENERIC name, storage requiremnts, strenght & qty

Front 18

GCP records

Back 18

1. formulatn record (recipes)
2. compounding record (Rx compounded)
3. maintenace record (for supplies)
4. Ingredient records (MSDS, purity)

Front 19

Properties of dosage form

Back 19

1. design
2. development
3. production (making large qty)
4. utilization (how to use)

Front 20

Hippocrates

Back 20

systemized medical knowledge, took medicine away from religion into science, "Father of Medicine"

Front 21

Galen

Back 21

books/writings compiling drugs/compounding "Galenic pharmacy"

Front 22

Dioscorides

Back 22

applied plants to pharmacy (pharmacognosy)

Front 23

Emperor Frederick II

Back 23

separated medicine & pharmacy

Front 24

Paracelsus

Back 24

-Swiss physician/chemist
-shifts pharmacy from botany-base to chemistry-base; begins matching drug to spp disease

Front 25

USP publication date, founding org

Back 25

1820; USP convention

Front 26

National Formulary publicatn date; founding org

Back 26

1888 APhA

Front 27

components of USP-NF monographs

Back 27

names, formulas, weight, purity, methods for assay, CAS #

Front 28

Food and Drug Act

Back 28

drug must have strength, purity, quality; DOESN'T mention safety/efficacy

Front 29

Sherley Amendment

Back 29

starts mandating can't have false claims

Front 30

Food, Drug, Cosmetic Act

Back 30

-triggered by sulfanilamide poisoning
-required safety of drugs, but NOT effectiveness
-created FDA
-drugs must have FDA approval

Front 31

Durham Humphrey Amendment

Back 31

categorized drugs as OTC or Rx

Front 32

Kefauver-Harris Amendment

Back 32

-triggered by thalidomide in Europe-teratogen
-must prove drug SAFE and EFFECTIVE b/f get FDA approval

Front 33

Comprehensive Drug Abuse Prevention and Control Act

Back 33

-created DEA
-created schedules for drugs of abuse classificatn

Front 34

Drug Listing Act

Back 34

-drug manufacturing firms must register w/ FDA
-starts National Drug Code (NDC) (manufacturer-product-package)

Front 35

Federal Anti-Tampering Act

Back 35

-resulted from tylenol tampering w/ cyanide
-req. tamper-resistant packaging

Front 36

Orphan Drug Act

Back 36

-triggered by AIDS/HIV
-gov't grants/patent xtensn to incr investigatn of new drugs

Front 37

Drug Price Competition and Patent Term Restoration Act

Back 37

-sped FDA approval for generics by allowing abbreviated applications
-xtend patent

Front 38

Prescription Drug Marketing Act

Back 38

-outlaw reimportatn of products
-restrict sample distributn/sale
-req. registration of wholesalers

Front 39

Prescription Drug User Fee Act

Back 39

-allow FDA to collect "user fees" from pharm companies
-funds used to hire more reviewers to assess drug apps

Front 40

Dietary Supplement Health and Education Act (DSHEA)

Back 40

-xclude herbs/ dietary spplemnts from regulatn
-Does not require FDA approval or safety/effectiveness testing
-can't advertise as "treatment"

Front 41

Food and Drug Administration Modernization Act (FDAMA)

Back 41

-streamlined FDA policies/regs
-pt easier access to clinical trials
-faster new drug approvals
-xtra 6 mos. patent incentive for research into pediatric use for drug

Front 42

desirable characs of "goal drug"

Back 42

-easy productn, low cost
-elegant
-stable in storage
-produce desired effect
-desirable route, min dosage/freq
-optimal onset, duratn of activity
-no side effects
-efficient eliminatn from body

Front 43

Define a "new drug" that would require FDA approval

Back 43

Any drug not recognized as safe & effective under conditions recognized for its use

Front 44

Discuss various techniques in drug discovery including random screening, molecular modification, mechanism-based drug design

Back 44

-Random Screening: bioassay/high throughput screening of synthetic organic or natural compounds
-Molecular Modification: chemical modificatn of known organic compound to incr usefulness as drug
-molecular modification in drug that interferes w/ biochemical pathway/disease mech

Front 45

Describe elements of preclinical drug studies: pharmacology, pharmacokinetics, toxicology, preformulation

Back 45

-pharmacology: selectivity/efficacy
-pharmacokinetics: rate/extent of drug absorptn- guide to dose/dose freq selectn
-toxicology- safety
-preformulatn- check drug properties that might affect formulatn into stable product

Front 46

increasing solubility by:

Back 46

-salt forms
-complexation
-decr particle size
-solubilizers
-change pH

Front 47

increase dissolution by:

Back 47

-incr SA
-incr concentratn gradient across membr
-decr dissolutn layer
-incr dissolutn const

Front 48

partitioning

Back 48

permeation dependent on relative lipid/aqueous solubility across membr