TL;DR
Therapeutic Equivalence: FDA Orange Book determination that a generic is bioequivalent and substitutable for the brand.
Therapeutic Equivalence
Definition
FDA Orange Book determination that a generic is bioequivalent and substitutable for the brand.
Practical Example
Pharmacy Calculation Example: dilution
Formula: C1V1 = C2V2
Worked example: Dilute 70% alcohol to 30%: (70)(V1) = (30)(500mL), V1 = 214.3 mL
Common Errors
Frequent errors with therapeutic equivalence in pharmacy practice:
- Misreading sig codes. For reference: OU = both eyes; OD = right eye; QID = four times daily; PO = by mouth; QHS = at bedtime; OS = left eye
- Calculation errors in dosage. Always double-check units (mg vs mcg, mL vs L)
- Wrong DEA schedule classification affecting storage and dispensing requirements
Exam Focus Areas
On the Ptcb exam(s), questions about therapeutic equivalence typically test:
- Mathematical calculations: dosage, days supply, dilutions, and compounding
- Drug classification, mechanism of action, and common side effects
- Federal and state regulations governing practice
Equipment & Tools
FDA Orange Book determination that a generic is bioequivalent and substitutable for the brand. AB-rated substitution tested on PTCB exam.
Related drug class: Benzodiazepines includes lorazepam, diazepam, alprazolam, midazolam. Mechanism: Enhance GABA-A receptor, increased chloride conductance, CNS depression.
Why It Matters
AB-rated substitution tested on PTCB exam.
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