pharmaceutical scientist
-design and develop new, safe, and effective meds
-drug discovery and delivery
-experts in chem and bio
registered pharm
-provide advice on the safe and effective USE of meds
-pt care, hospitals, and pharmacies
drug substance
-has active pharmaceutical ingredient (API)
-any chemical substance or biologic used in diagnosis, treatment, or cure of a disease
brand name drug
-drug marketed under proprietary, trademarked name
generic drug
-same drug as brand name
-has same active ingredient, dosage form, safety, strength, indented use, performance, and route of administration
drug product/dosage form
-combo of API and excipients to make dosing administration, delivery for a pt
-includes oral, topical, and inhalation
oral dosage forms
-tablets, capsules, granules, powders
-solutions, suspensions, and emulsions
OTC (non-prescription durgs)
-safe and effective to use without needing advice
-low potential for abuse
-same Rx standards of safety, efficacy, labeling, and quality
most OTC are _____ packaging
tamper-resistant
Some OT are dispensed by pharmacists, which are they?
-abused drugs
OTC examples
-cough and congestion meds
-cold and flu meds
-nasal solutions
-mild pain reliver (acetaminophen)
some OTC are from the same brand, but different why?
-have different or multiple APIs
-different duration of action
dietary supplements
-intended to add to diet and different from regular food
-taken orally in tablets, capsules, gels, powders, bars, gummies, etc
do dietary supplements need prescriptions? why?
-no
-they DO NOT contain a drug substance
for herbal products what must the label include?
part of plant used
medical device
instrument that doesn’t achieve its primary purpose through chemical action in or on body
classifications of med devices
class I: most devices dont need 501K (bandied, crutches, wheelchair)
class II: needs 501K (injections, blood pressure stuff)
class III: needs premarket approval (heart device)
pharmaceutical quality
assuring every dose is safe and effective, free of defects and contamination