Regulatory Affairs & Quality Assurance PYQs – Set 170
Subject : Regulatory Affairs & Quality Assurance
3381. For OTC oral products intended for children under 6 years of age, the recommended alcohol content limit is:
Regulatory Affairs & Quality Assurance • • NIPER 2015
3382. The historically first international guideline pertaining to research involving human participants was the:
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3383. As per DPCO 2013, what is the method of drug pricing?
Regulatory Affairs & Quality Assurance • • NIPER 2015
3384. Which of the following is not patentable subject matter?
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3385. Who is the ex-officio member of PCI?
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3386. In ANDA, the generic drug product is compared with innovator drug to observe:
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3387. Schedule G drugs:
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3388. ICH guidelines for dissolution testing are given in:
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3389. Good Laboratory Practice (GLP) certification is issued in India by:
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3390. Clathrates are:
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3391. The Ministry of AYUSH was formed in:
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3392. Hatch-Waxman act is related to:
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3393. Which of the following are not necessary for ANDA review processes?
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3394. The list of diseases and ailments that a drug should not claim to cure are given in the following schedule of Pharmacy Act, 1940:
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3395. Indian Medicine Pharmaceutical Corporation Limited (IMPCL), a public sector undertaking by AYUSH is located in:
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3396. For a generic drug to be bioequivalent to an innovator drug (per FDA), it must be measured in _____ of subjects to fall within _____ of the mean of the test population bioavailability:
Regulatory Affairs & Quality Assurance • • NIPER 2015
3397. The Declaration of Helsinki is a document of:
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3398. The Indian Pharmacopoeia 2018 is ______ edition
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3399. Which schedule is related to the shelf life of drug formulations
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3400. Headquarters of IPC commission is at
Regulatory Affairs & Quality Assurance • • NIPER 2015
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