BSN 315 CHAPTER 2: New Drug Development and
Approval Process – Questions & Solutions
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Terms in this set (53)
The federal Food, Drug, and Cosmetic 1. Must demonstrate, **through supporting scientific
Act, requires a new drug to be evidence**, that the new drug or drug product is safe
approved by the Food and Drug and effective for its proposed use.
Administration (FDA) before it may be
legally introduced in the interstate 2. Must demonstrate that the various processes and
commerce. The regulations apply to the controls used in producing the drug substance and in
drug products manufactured manufacturing, packaging, and labeling are properly
domestically and those imported into controlled and validated to ensure that the product
the United States. meets the established standards of quality.
To gain approval for marketing a drug's
sponsor (e.g., a pharmaceutical
company):
, The process and time course from drug 1. After the discovery
discovery to approval for marketing can
be lengthy and tedious but are well 2. pharmacologic
defined and understood in the
pharmaceutical industry. A schematic 3. toxicologic
representation of the process for new
drug development is shown below: 4. therapeutic application
5. preclinical
______(1)_______ (e.g., synthesis) of a
proposed new drug, the agent is 6. clinical
biologically characterized for
________(2)______ and ________(3)_______ effects
and for potential ________(4)_________.
Preformulation studies are initiated to
define the physical and chemical
properties of the agent. Formulation
studies follow to develop the initial
features of the proposed
pharmaceutical product or dosage
form. To obtain the required evidence
demonstrating the drug's safety and
effectiveness for its proposed use, a
carefully designed and progressive
sequence of _______(5)_____ (e.g., cell
culture, whole animal) and ______(6)______
(human) studies is undertaken.
Approval Process – Questions & Solutions
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Play your way to mastery with fun games
Match Blocks Charms NEW
Terms in this set (53)
The federal Food, Drug, and Cosmetic 1. Must demonstrate, **through supporting scientific
Act, requires a new drug to be evidence**, that the new drug or drug product is safe
approved by the Food and Drug and effective for its proposed use.
Administration (FDA) before it may be
legally introduced in the interstate 2. Must demonstrate that the various processes and
commerce. The regulations apply to the controls used in producing the drug substance and in
drug products manufactured manufacturing, packaging, and labeling are properly
domestically and those imported into controlled and validated to ensure that the product
the United States. meets the established standards of quality.
To gain approval for marketing a drug's
sponsor (e.g., a pharmaceutical
company):
, The process and time course from drug 1. After the discovery
discovery to approval for marketing can
be lengthy and tedious but are well 2. pharmacologic
defined and understood in the
pharmaceutical industry. A schematic 3. toxicologic
representation of the process for new
drug development is shown below: 4. therapeutic application
5. preclinical
______(1)_______ (e.g., synthesis) of a
proposed new drug, the agent is 6. clinical
biologically characterized for
________(2)______ and ________(3)_______ effects
and for potential ________(4)_________.
Preformulation studies are initiated to
define the physical and chemical
properties of the agent. Formulation
studies follow to develop the initial
features of the proposed
pharmaceutical product or dosage
form. To obtain the required evidence
demonstrating the drug's safety and
effectiveness for its proposed use, a
carefully designed and progressive
sequence of _______(5)_____ (e.g., cell
culture, whole animal) and ______(6)______
(human) studies is undertaken.
