KAPS Study Guide 2026
Everything you need to pass the KAPS exam in one place: the exam format, every topic to study, real practice questions with explanations, flashcards, and full-length practice tests. Free, no sign-up needed.
📋 KAPS Exam Format at a Glance
📚 KAPS Topics to Study (63)
✍️ Sample KAPS Questions & Answers
1. Under 21 CFR Part 314, what is the standard review period for a standard NDA after it is accepted for filing?
The standard FDA review goal for an NDA under PDUFA is 10 months from the date of filing.
2. A pharmacist who disagrees with a physician's therapeutic choice for a patient should:
Pharmacists have a professional duty to communicate therapeutic concerns to prescribers collaboratively while respecting the prescriber's clinical authority.
3. Which spectroscopic technique measures the absorption of infrared radiation to identify functional groups in a drug molecule?
Infrared spectroscopy identifies functional groups based on characteristic bond vibration frequencies in the IR region.
4. Which analytical technique provides both molecular weight and structural fragmentation information simultaneously?
Mass spectrometry ionizes molecules and measures mass-to-charge ratios of the parent ion and fragment ions, giving MW and structural data.
5. In an IVIVC (in vitro–in vivo correlation), a Level A correlation is considered MOST valuable because it:
A Level A IVIVC provides the highest predictive value by establishing a point-to-point relationship between the entire in vitro dissolution profile and the in vivo absorption profile.
6. A pharmacist receives a prescription for nitroglycerin 0.4 mg sublingual tablets. Which counseling point about storage is MOST critical?
Nitroglycerin is volatile and degrades when exposed to light, heat, or moisture; it must be stored in the original amber glass bottle tightly capped.