1.
Friability test is official in Indian Pharmacopoiea ...
Correct Answer
A. True
Explanation
The statement is true because the Friability test is indeed official in the Indian Pharmacopoeia. The Indian Pharmacopoeia is a book of standards for drugs and pharmaceuticals in India, and it includes various tests and specifications for quality control purposes. The Friability test is a test used to assess the durability of tablets or granules by subjecting them to mechanical stress. As it is mentioned that the test is official in the Indian Pharmacopoeia, it implies that it is recognized and recommended by the regulatory authorities in India for evaluating the quality and stability of pharmaceutical products.
2.
As per IP, Content uniformity test is applicable to tablets when dose is
Correct Answer
E. A and B
Explanation
The content uniformity test is applicable to tablets when the dose is less than or equal to 10mg or less than or equal to 10% of the tablet weight. This test ensures that the active ingredient is distributed evenly throughout the tablet, allowing for consistent dosing. By testing the content uniformity, manufacturers can ensure that each tablet within a batch contains the correct amount of active ingredient, providing reliable and accurate medication for patients.
3.
A patent gives the owner the right to:
Correct Answer
C. Keep others from making her invention
Explanation
A patent gives the owner the right to keep others from making her invention. This means that the owner has exclusive control over the production and manufacturing of the invention, preventing others from using or reproducing it without permission. The patent also provides legal protection against infringement, allowing the owner to take legal action against anyone who violates their rights. This ensures that the inventor has the opportunity to benefit financially from their invention and maintain a competitive advantage in the market.
4.
The minimum requirements for obtaining a patent are that the invention must be:
Correct Answer
E. A and B and C
Explanation
The correct answer is A and B and C. In order to obtain a patent, the invention must meet all three requirements: it must be novel, meaning it is new and hasn't been previously disclosed; it must be non-obvious or include an inventive step, meaning it cannot be something that would be obvious to a person skilled in the relevant field; and it must be useful or capable of industrial application, meaning it has a practical purpose and can be produced or used in some form of industry. Therefore, all three conditions must be satisfied for a patent to be granted.
5.
If you want to know what is actually covered by a granted patent, you will look at:
Correct Answer
F. The claims
Explanation
The claims are the part of the patent specification that set the boundaries of what is subject to the right to exclude others. A claim describes in legal terms what the patent rights holder owns. The meaning of the claims is determined by the language of the claims, aided by the text of the patent and the "prosecution history", the record of the patent examination process. In the case of a patent application, the claims delimit what the applicant wishes to own and have no legal force. The specification, also called the disclosure, is the written description of the invention. It comprises the title, the abstract, the drawings, and the text of the patent, comprising the background, summary of the invention, the detailed description of the invention, and the examples. Not all patents have each of these sections. The title of a patent is like a headline of a newspaper; it is not necessarily indicative of the scope of patent protection. The abstract of a patent gives a general idea of what is contained in the patent specification, but it is also not necessarily complete. Unfortunately on many patent databases, searching is limited to titles or abstracts. This limitation is not in the public interest. The text of a patent is a valuable resource for getting to know the particulars of the invention, including its advantages, the problems that it is intended to solve, how the invention was achieved, other possible ways of generating the same result and how to practice the invention through different examples. Despite the comprehensiveness of the detailed description, it does not delimit the subject matter protected by a patent; aspects described in this section serve to illustrate and clarify the invention and how the inventors envision the invention could be applied. The matter that is described in the specification but not covered in the claims may be free to use unless it's covered in another patent!
6.
Patents have a limited lifetime.
Correct Answer
A. True
Explanation
In most countries now, a patent lasts for 20 years from the date of filing, provided required maintenance fees are paid. This period is the monopoly period granted to the owner of the patent.
7.
FDA defines OTC drugs as safe and effective for use by the general public without a doctor's prescription.
Correct Answer
A. True
Explanation
The statement is true because the FDA (Food and Drug Administration) has specific regulations in place for over-the-counter (OTC) drugs. These regulations ensure that OTC drugs are safe and effective for use by the general public without needing a doctor's prescription. This means that individuals can purchase and use OTC drugs without the need for professional medical guidance, as they have been deemed safe and effective by the FDA.
8.
A prescription drug product requires a doctor's authorization to purchase.
Correct Answer
A. True
Explanation
Prescription drugs are medications that are regulated by the government and are only available with a doctor's authorization. This is done to ensure that the drug is used safely and appropriately, as certain medications can have potential risks and side effects. Without a doctor's authorization, it is illegal to purchase prescription drugs. Therefore, the statement that a prescription drug product requires a doctor's authorization to purchase is true.
9.
FDA regulates
(more than 1 option can be chosen)
Correct Answer(s)
A. Foods
B. Dietary Supplements
C. Human Drugs
D. Vaccines, Blood Products, and Other Biologics
E. Medical Devices
F. Electronic Products
G. Cosmetics
H. Veterinary Products
I. Tobacco Products
Explanation
The FDA regulates a wide range of products including foods, dietary supplements, human drugs, vaccines, blood products, and other biologics, medical devices, electronic products, cosmetics, veterinary products, and tobacco products. This includes ensuring the safety, effectiveness, and proper labeling of these products, as well as monitoring their manufacturing, distribution, and advertising practices. The FDA also regulates the sale and distribution of illegal drugs of abuse, such as heroin and marijuana, and oversees the labeling and advertising of alcoholic beverages.