Pharmaceutics Exam #1 Material (25% of Final Exan
Introduction to Drugs and Pharmacy
What is NF and USP? Why was it critically important to adopt these legal documents? NF National Formularies & USP United States Pharmacopeia o These are organized sets of monographs or books of standards o 1st one was in 1820 o developed due to the need for established uniform standards & ensure quality safety Standards for drugs, pharmaceutical ingredients & dosage forms - Provides information on tests & assay procedures for demonstrating compliance with these standards o USP and NF contain information for individual components of drugs NoT combinations o Written with high degree of clarity and specificity and reflect the best current practices of medicine
What is the function of the CDER (Center for Drug and Evaluation Research)?
A division of the FDA Assesses benefit to risk relationships o Is a particular drug safe and effective enough? :Ex; AZT is toxic but effective against HIV Once a drug has been developed, it gets filed with the FDA using an investigational new drug (IND) application and an CDER official is assigned to review that drugfi They can place a hold on clinical trials due to inadequate information, inadequate qualifications of investigators or significant risk or harm to patients
What is the Food and Drug Act of 190fi? Law that required drugs marketed interstate comply with claimed standards for strength, purity and quality Sherly amendments = prohibited labeling medications with false therapeutic claims intended to defraud the user no more false claims NOTE: nothing about safety or efficacy yet : declared products misbranded
As the result of the sulfanilamide tragedy, the Federal Food, Drug, and Cosmetic Act of 1938 was passed. What did that entail? Required that all new drugs be tested by their manufacturers for safetyfi Required that those tests be submitted to the government for marketing approval via the NDA (new
Approval was granted based on many factors, including pharmacology and toxicology (both tested in the preclinical trials) Mandated that drugs be labeled with adequate directions for use NOTE: nothing about drug efficacy Authorized FDA to conduct unannounced inspections as of yet, only drug safety
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What is the name of the agent that caused the Sulfanilamide Tragedy? Was the problem ingredient an excipient or the active agent? (i) What was the finished preparation intended to treat? (ii) Could this tragedy have been prevented? How?
Explain the sulfanilamide tragedy. "Wonder drug" was manufactured by S. E. Massengill Company as an elixer, but diethylene glycol (not an elixir) was used as the solvent to prepare the elixir o diethylene glycol is anti-freeze...fipoisonous Se pudo haber utilizado Propylene Glycol para
Who was Frances Kelsey, and why did President Kennedy award her the Distinguished Federal Civilian Service Award?
Frances Kelsey worked as an NDA reviewer for the FDA and denied authorization for Thalidomide for
market because of concerns about the drug's safetyfi Prevented Phocomelia in babies born in Trump country
As a result of the thalidomide tragedy,