Concept and development of generic drug products MCQs With Answer

Concept and development of generic drug products is a core topic for B. Pharm students covering how pharmaceutically equivalent medicines are formulated, tested, and approved for market entry. This introduction explores key concepts: generic drug definition, regulatory pathways like ANDA, reference-listed drug (RLD), bioequivalence (BE) study design, therapeutic equivalence, formulation and excipient considerations, dissolution testing, biowaivers under the BCS, stability and quality control, and post-marketing surveillance. Emphasis is on practical development steps, critical quality attributes, and regulatory acceptance criteria that ensure safety, efficacy, and interchangeability. Learning these principles prepares students for formulation, analytical, and regulatory roles in the pharmaceutical industry. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the most accurate definition of a generic drug product?

• A new chemical entity with improved efficacy
• A drug product that is pharmaceutically equivalent and bioequivalent to the reference listed drug
• A branded drug marketed under a different name
• A biological product derived from living cells

Correct Answer: A drug product that is pharmaceutically equivalent and bioequivalent to the reference listed drug

Q2. Which regulatory submission is required in the USA to market an approved generic small-molecule drug?

• New Drug Application (NDA)
• Biologics License Application (BLA)
• Abbreviated New Drug Application (ANDA)
• Investigational New Drug (IND) application

Correct Answer: Abbreviated New Drug Application (ANDA)

Q3. Which parameter is most commonly used to demonstrate bioequivalence in pharmacokinetic studies?

• pH of the formulation
• Maximum plasma concentration (Cmax) and area under the curve (AUC)
• Tablet hardness
• Color of the finished product

Correct Answer: Maximum plasma concentration (Cmax) and area under the curve (AUC)

Q4. What is the usual FDA bioequivalence acceptance criterion for AUC and Cmax?

• 90% confidence interval of 70–130%
• 90% confidence interval of 80–125% on log-transformed data
• 95% confidence interval of 90–110%
• 95% confidence interval of 50–200%

Correct Answer: 90% confidence interval of 80–125% on log-transformed data

Q5. What is a Reference Listed Drug (RLD)?

• The generic product that was first approved
• The innovator drug product to which equivalence is compared
• An over-the-counter formulation with the same name
• A biologic reference standard

Correct Answer: The innovator drug product to which equivalence is compared

Q6. Which Biopharmaceutics Classification System (BCS) classes are commonly eligible for a biowaiver?

• Class II and IV
• Class I and III
• Class III and IV
• Class I and II

Correct Answer: Class I and III

Q7. What does therapeutic equivalence imply for a generic product?

• Same branding and packaging as the innovator
• Pharmaceutical equivalence and bioequivalence, allowing safe substitution
• Identical inactive ingredients only
• Lower manufacturing costs

Correct Answer: Pharmaceutical equivalence and bioequivalence, allowing safe substitution

Q8. Which dissolution test metric is commonly used to compare generic and marketed products?

• Similarity factor (f2)
• Disintegration time only
• Colorimetric index
• Viscosity measurement

Correct Answer: Similarity factor (f2)

Q9. For an immediate-release oral solid dosage form, which USP apparatus is most commonly used for routine dissolution testing?

• USP Apparatus IV (flow-through)
• USP Apparatus II (paddle)
• USP Apparatus V
• USP Apparatus IIA

Correct Answer: USP Apparatus II (paddle)

Q10. Which factor is considered a Critical Quality Attribute (CQA) during generic product development?

• Color of the marketing brochure
• Particle size distribution affecting dissolution
• Name of the contract manufacturer
• Number of employees in QA

Correct Answer: Particle size distribution affecting dissolution

Q11. What is the primary purpose of conducting stability studies for a generic product?

• To reduce manufacturing costs
• To establish shelf life and storage conditions ensuring potency and safety
• To determine the color of packaging
• To check employee competency

Correct Answer: To establish shelf life and storage conditions ensuring potency and safety

Q12. Which study design is most commonly used for bioequivalence studies of immediate-release drugs?

• Parallel group design with large sample sizes
• Two-period, two-sequence crossover design
• Open-label long-term safety study
• Single-arm historical control study

Correct Answer: Two-period, two-sequence crossover design

Q13. What role do excipients play in generic formulation development?

• Excipients are inert and have no effect on performance
• Excipients influence stability, dissolution, manufacturability, and bioavailability
• Excipients determine the patent status of the drug
• Excipients replace the active ingredient

Correct Answer: Excipients influence stability, dissolution, manufacturability, and bioavailability

Q14. Which regulatory document lists therapeutic equivalence codes for approved drugs in the USA?

• The Blue Book
• The Orange Book
• The Green Book
• The Red Book

Correct Answer: The Orange Book

Q15. What does an “AB” code in the FDA Orange Book indicate?

• Product is a biologic and not substitutable
• Multiple products are pharmaceutically equivalent and bioequivalent to the RLD
• Product is discontinued
• Product requires a Risk Evaluation and Mitigation Strategy (REMS)

Correct Answer: Multiple products are pharmaceutically equivalent and bioequivalent to the RLD

Q16. Which analytical method is most important for quantifying drug content in dissolution samples?

• UV–visible spectrophotometry or validated HPLC
• Guessing based on color intensity
• Particle size analysis
• Thermogravimetric analysis

Correct Answer: UV–visible spectrophotometry or validated HPLC

Q17. When is a biowaiver based on dissolution data and BCS most appropriate?

• For poorly soluble, highly permeable drugs with complex release
• For highly soluble, highly permeable drugs with rapid dissolution in multiple media
• For sterile injectable products only
• For topical creams with local action only

Correct Answer: For highly soluble, highly permeable drugs with rapid dissolution in multiple media

Q18. Which parameter indicates in vivo rate of absorption?

• Tmax
• Tablet friability
• pKa of excipient
• Package insert font size

Correct Answer: Tmax

Q19. What is the impact of narrow therapeutic index (NTI) drugs on generic approval?

• NTI status relaxes bioequivalence limits
• NTI drugs require stricter bioequivalence criteria and careful substitution policies
• NTI drugs are excluded from generic competition
• NTI status only affects packaging design

Correct Answer: NTI drugs require stricter bioequivalence criteria and careful substitution policies

Q20. What is the purpose of performing in vitro–in vivo correlation (IVIVC)?

• To replace pharmacovigilance activities
• To predict in vivo drug performance from in vitro dissolution and support formulation changes
• To evaluate marketing strategies
• To determine packaging material compatibility

Correct Answer: To predict in vivo drug performance from in vitro dissolution and support formulation changes

Q21. What must a generic manufacturer identify in an ANDA in relation to patents?

• Only the chemical synthesis route of the RLD
• Patent certifications or paragraph IV certifications regarding listed patents
• Employee biometrics
• The marketing price of the RLD

Correct Answer: Patent certifications or paragraph IV certifications regarding listed patents

Q22. Which manufacturing practice is essential to ensure generic drug quality?

• Good Manufacturing Practice (GMP) compliance
• Minimal quality testing to reduce costs
• Unrecorded manual adjustments
• Outsourcing all responsibilities without oversight

Correct Answer: Good Manufacturing Practice (GMP) compliance

Q23. Which excipient-related issue can most directly alter bioavailability of a generic product?

• Tablet printing ink color
• Use of a surfactant that enhances solubility
• Shape of the outer carton
• Supplier logo placement

Correct Answer: Use of a surfactant that enhances solubility

Q24. What is the recommended washout period in a crossover BE study based on?

• Country of study
• At least five half-lives of the drug to avoid carryover
• Number of subjects enrolled
• Color of the dosing container

Correct Answer: At least five half-lives of the drug to avoid carryover

Q25. Which post-approval activity is important to monitor generic drug safety and quality?

• Pharmacovigilance and adverse event reporting
• Ad campaigns only
• Weekly sales promotions
• Endless stability studies without reporting

Correct Answer: Pharmacovigilance and adverse event reporting

Q26. What is the main reason for performing dissolution method development during generic product development?

• To create a visually appealing test
• To develop a discriminatory, reproducible method that reflects in vivo release and supports BE/biowaiver
• To avoid any regulatory testing
• To measure tablet color stability

Correct Answer: To develop a discriminatory, reproducible method that reflects in vivo release and supports BE/biowaiver

Q27. Which of the following best describes ‘pharmaceutical equivalence’?

• Same active ingredient, dosage form, route, strength, but may differ in inactive ingredients
• Same marketing claim and price
• Identical manufacturing site and equipment
• Different active pharmaceutical ingredient but similar effect

Correct Answer: Same active ingredient, dosage form, route, strength, but may differ in inactive ingredients

Q28. In bioequivalence statistical analysis, why are data log-transformed?

• To make numbers smaller for easier reading
• To normalize skewed pharmacokinetic data and allow ratio-based confidence intervals
• To obscure raw data from regulators
• To convert concentrations into pH values

Correct Answer: To normalize skewed pharmacokinetic data and allow ratio-based confidence intervals

Q29. Which of the following can disqualify a generic product from receiving an immediate approval?

• Complete match of inactive ingredients with RLD
• Failure to demonstrate bioequivalence or unresolved quality deficiencies
• Lower manufacturing costs than innovator
• Use of approved analytical methods

Correct Answer: Failure to demonstrate bioequivalence or unresolved quality deficiencies

Q30. Why is scale-up and process validation critical in generic drug manufacturing?

• To reduce workforce training
• To ensure consistent product quality, reproducibility, and compliance when moving from lab to commercial production
• To change the active ingredient at large scale
• To avoid performing dissolution testing

Correct Answer: To ensure consistent product quality, reproducibility, and compliance when moving from lab to commercial production

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