Regulation of Biopharmaceutical Products Quiz
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Industrialized nations have created ______ to regulate the use of biopharmaceutical products.

watchdogs

The regulatory agencies are to protect public health by ensuring products are ______ and will benefit patients.

safe

Technically, drugs are small-molecule chemical products that are shown to benefit public health, can be safely administered, and can be manufactured to high ______.

quality

Biologics are large-molecule products that are being developed and marketed on a more routine basis, examples include ______, blood-derived products, insulin, gene and cell therapy, etc.

<p>vaccines</p> Signup and view all the answers

______ are examples of biologics.

<p>Vaccines</p> Signup and view all the answers

Under the assumption that drugs, biologics, vaccines are unsafe or will not benefit patients or have poor quality, the regulatory agencies are tasked to ______ and the few biopharmaceutical products which are...

<p>withdraw</p> Signup and view all the answers

Industrialized nations have created watchdogs to regulate the use of ______ products.

<p>biopharmaceutical</p> Signup and view all the answers

The regulatory agencies are to protect public health by ensuring products are ______ and will benefit patients.

<p>safe</p> Signup and view all the answers

Biologics are large-molecule products that are being developed and marketed on a more routine basis, examples include vaccines, blood-derived products, insulin, gene and cell therapy, etc. We will refer to biopharmaceutical products as ______.

<p>drugs</p> Signup and view all the answers

Technically, drugs - small-molecule chemical products that are shown to benefit public health, can be safely administered, and can be manufactured to high ______.

<p>quality</p> Signup and view all the answers

Sponsors must show that their products are safe, effective, and made to high-______ standards.

<p>quality</p> Signup and view all the answers

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