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What is the drug supply chain
supplier -> manufacturer _> wholesaler -> pharmacy -> patient
repackager or secondary wholesaler may also exist
What are some reasons for recalls? Which of these are especially important for sterile injectables?
- equipment breakdown*
what are some contributing factors for drug shortages?
- few producers
- specialized facilities
- dedicated lines
- just in time inventory
What is the drug manufacturing process? At which stages does pharmaceutical analysis occur?
- *Arrival of starting and packaging materials: ensure identity+ purity
- Sampling of starting materials
- manufacturing-analysis of product
- *Documentation and control of finished product and product release
What are some roles of pharm. analysis?
- ssurance of raw material and drug product quality and stability
- evaluation of drug PK
- therapeutic drug monitoring
- clinical and forensic tox. analysis
- analysis of blood/urine samples
What are the wavelengths of different spectrums?
At what range are weaker bond electrons excited?
At what range do solves and air absorb?
- UV: 200-380
- IR: >800
What is a chromophore?
How can you predict if something will be a chromophore?
- Afunctionalgroup in amolecule thatcan absorb radiation
- Presence of a pi bond
Why are quartz cuvettes preferred over glass/plastic?
High transmittance, esp. in low wavelength range, compared to glass and plastic (190-300 nm range)
What is the beer Lambert law?
What is the single-point equation?
A= log [Io/I]
A= E * b * [c]
E= extinction co-efficient
Cunk= Csta * A unk/ Asta
What are two ways to measure the concentration of a species using UV-vis?
- Standard curve method
- Single point method
What are some advantages and disadvantages of UV-vis?
- cheap and easy
- non-specific and background absorbance
What are some advantages and disadvantages of fluorescence spectroscopy?
- more useful and specific but many drugs aren't fluorescent
- proportional to intesnity oflight
- background fluorescence is theoretically zero
- 10,000X more sensitive than UV-vis
- highly specific
physical method of seperating 2 or morecomponents based on their distribution between 2 phases; stationary and mobile phase.
Can identify, determine purity, and assay
What characteristic does HPLC use to separate?
Based on partitioning between stationary and mobile phase according to affinity for polar or hydrophobic resins
How can you use HPLC to identify something quantitatively? Qualitatively?
- qualitative: identify by chromatographic characteristic
- quantitative: identify by AUC relative to standard
What does residence time depend on?
- Type of resin
- Type of solvent
- Flow rate
- Type of compound
What are the normal phase solvents in increasing polarity?
What are the reverse phase solvents in increasing non-polarity?
Hexane, dichloromethane, isopropanol, methanol
Water, methanol, acetonitrile, tetrahydrofuran
What happened in 1937?
- Sulfaniliamide in ethylene glycol crises
- 107 deaths
When was health Canada founded? FDA?
1920: Health CanadaFood and Drug Act
1906: U.S. Pure food and drug act
1938: formalized the 1906 act into the U.S. Federal food, Drug and Cosmetic Act[ required new drugs to show safety, in response to sulfanilamide]
What was the Kefauver-Harris Drug amendments? When did it occur? Who was Frances Kelly?
- In response to thalidomide
- drug must besafeand effective
- Frances Kelly: Demonstrates role of regulatory agency in protecting public; demonstrates a need for reporting + registering adverse events
What are some specific responsibilities of Health Canada?
- Review CTA
- review Drug submissions
- monitor safety of drugs on Can. Market, and community safety risk of HCP and public, in collaboration with industry
- Enforce industry's compliance with regulations [clinical trials, manufacturing, ADR reporting]
What is the progression of gaining drug approval
- regulatory product submission
- submission review
- market authorization decision
- public access
What are the parts of a NDS?
- master volume
- chemistry and manufacturing
- comprehensive summary
- sectional reports
- raw data
How may polymorphs differ?
What was the example she used in class?
- metlting point
What is QA?
Wideranging concept that covers all matters that individually or collectively influence the quality of a drug
What is GMP
part of QA that ensures drugs are consistently produced and controlled in such a way to meet the quality standard of their intended use
What is QC
- Part of GMP concerned with sampling, specifications, testing, documentation, and release procedures
- Ensures products released are of satisfactory quality
What are the key elements of GMP?
- Suitable equipment and services
- Suitable storage and transport
- Adequate premises and space
- approved procedures and instructions
- qualified and trained personnel
- correct materials containers and labels
What are specifications?
- a detailed description of a drug, the raw material used in a drug, or a packaging material for a drug and includes:
- -a statement of properties and qualities of a drug
- -detailed method of testing
- -a statement of tolerances for the properties and qualities of the drug, raw material, packaging
What are some raw specs of Acetaminophen USP?
- Purity : 98-101%; UV-vis @ 244 nm
- Water content: <0.5 nm
- Residue on ignition test < 0.1 %
- Heavy metals: <0.001 %
- Free p-aminophenol < 0.005% (UV-vis)
- Free p-chloroacetanilide <0.001% (TLC)
What are some raw specs of acetaminophen tablets USP?
- Potency- contains 90-110 % of labelled drug as measured by HPLC
- Identification- tR corresponds to acetaminophen standard
- Dissolution- not less than 80% of drug dissolved in pH 5-8 phosphate buffer in 30 mins
What must companies do with respect to specs for new drugs?
- Companies must establish new specs - develop " in-house" standards
- specs have to follow accepted principles
- must synthesize reference standard
What are some general USP tests?
- Residual solvents (GC)
- Inorganic compounds: residue on ignition test
- heavy metals: react with thioacetamide glycerin
- water content: Karl Fisher titration
What are some properties of sterile products?
- pH 5-8
- very low endotoxin levels
- packaged in a way that maintains these properties
What is the sterility test?
- 14 day incubation on 2media
- soybean casein medium
- fluid thioglycholate broth
How are injectables sterilized?
- aseptic filtration through a 0.22 mcm filter
Describe the USP pyrogen test
Describe the USP bacterial endotoxin test
- for gram- endotoxin
- relies on formation of a clot in test-tube when sample of drug product is incubated with the lysate from blood cells of horse shoe crab for 1 hour at 37degrees
What is the european equivalent of the TPD
rate and extent of absorption of a drug systematically
profile of drugs are similar in comparable dosage forms and dose
Define generic drug:
drug product that compares to the pioneer, reference drug, in dosage form, strength, route of administration, quality and performance characteric, and intended use.
What is the Hatch-Waxman Act?
What are the things it enacted?
- Drug price competition and patent restoration act
- Sponsor must establish BE, and adhere to FDA approved manufacturing process
- sponsor may conduct BE traisl before innovator patent expires
- "first-to-file": the first generic to file an application gets 180 days of exclusivity.
What are the parts of a NDA?
What study is always done?
Single-dose fasting bioavailability study
What are some competitive tactics in the generic/pioneer drug business?
- Generics establish exclusivety with supplier of API
- IR-> ER before patent expires
- innovators create their own generic
- innovator will pay off generic to delay release
How do critical dose drugs differ in BE?
- AUCt, ref 90%CI between 90-112%
- Cmax: 90% CI between 80-125%
- if time of release is important:
- AUCtmax value between 80-125%
Name some critical dose drugs