last minute foundations info

which drugs should you not take while pregnant as the drug can pass through the amnionic sac?

PRIL

SARTAN

KIRENS

what should you not take with PRILS?

• lithium carbonate

• triamterine

• NSAID

• pottasium supplements

• Renin Blockers (Kiren), ACE-I (prils) , ARBS (sartan)

which drugs should you not take with SARTANS (drug interactions)

potassium supplements

which drugs should you not take with KIRENS (drug interactions)

• cyclosporine

• itraconazole

• ARBS, ACE-1

what is the difference between DHP and non DHP DIPINES?

DHP block calcium — prevent smooth muscle contraction of vessels (vasodilate)

nonDHP — decrease heart rate by depressing AV node conduction

blood pressure = SVR x CO

what are the nonDHP drugs

diazepam and verapamil

which countries have the Bismarck Model (payroll taxes) which part of US has this model?

germany, netherlands, france, japan

affordable care act — pay based on taxes how much you make

Which countries have the National Health Care model? which part of US has this model?

Canada, South Korea (very dif than north)

CMS

Which countries have the beveridge model? Which part of US has this model?

united kingdom and cuba

VA (america loves their veterans)

what is the one type of kiren?

aliskiren

Which countries have the out of pocket model? which part of US has this model?

india, south america, china

many left uninsured

two types of private healthcare

which is more expensive?

HMOs —Health Maintenance Organizations (less options but cheap)

PPO— Preffered Provider Organizations (more options so more expensive)

SEQ drug discovery process for small molecules

target identification/ validation

lead

candidate (use models—in vitro — surrogate input)

preclinical (test animals — in VIVO)

IND (investigation new drug)

clinical

• phase 1 (20-50)

• phase 2 (100-500)

• phase 3 (1000-5000)

NDA (new drug administration) also called CDER (Center for drug evaluation and research)

Phase 4

SEQ drug discovery process for biologics (>1000)

target identification/ validation

lead

candidate (use models—in vitro — surrogate input)

preclinical (test animals — in VIVO)

IND (investigation new drug)

clinical

• phase 1 (20-50)

• phase 2 (100-500)

• phase 3 (1000-5000)

BLA (Biologics License Application) also called (Center for Biologic Evaluation and research)

3+ 3 process

after preclinical trials and submitting the IND how long can you wait after not hearing a response back from the FDA?

30 days

what can accelerate the drug discovery process?

if there is strong evidence that the drug will work (HARVEY for HepC)

if there is an unmet medical need (Alzheimer’s)

Phase 3 is initiated if justified by the proof of concept in which steps? what happens in each phase

• phase 1b and phase 2b

phase 1b = dose escalation to establish MTD

and RP2D (recommended phase 2 dose) for cancer patients ALSO determine preliminary tumor effect and tolerability

phase 2b = RP2D to cancer patients to determine preliminary efficacy and tolerability

which step of the drug discovery process is the maximum tolerated dose (MTD) established?

phase 1

How many healthy volunteers are there in phase 1 ? how many times are their blood drawn?

15-18 healthy volunteers

12-15 blood draws each (more frequent in first 2 hours of drug administration)

how does one determine the Max Tolerated Dose (MTD)

• grade 4 nuetropenia

• grade 3 nuetropenia with fever

• grade 4 thrombocyrtopenia

• grade 3-4 non-heme toxicity

if any of these are experienced by humans in clinical trials they have reached the max dose