Pharmaceutics Midterm Exam 1 || || || ||
Questions With Answers || || ||
According to the FDA, New drug is defined:
|| || || || || || ||
Any drug that is NOT recognized as being safe and
|| || || || || || || || || ||
effective in the conditions recommended for its use in the
|| || || || || || || || ||
labeling among qualified experts
|| || || ||
A new chemical entity
|| || ||
A new formulation or method of manufacture of 'old
|| || || || || || || || ||
drug'
A new combination (including proportions) of two or
|| || || || || || || ||
more old drugs || ||
A new use/route of administration/dosage form for an
|| || || || || || || ||
established drug ||
,What is the approximate ratio of potential compounds
|| || || || || || || ||
that enters the drug development process to the number
|| || || || || || || || ||
of products that ultimately gets the FDA approval?
|| || || || || || ||
1:10,000
The science that deals with the adverse effects of drugs
|| || || || || || || || || ||
is known as:
|| ||
Toxicology
Preformulations Studies: ||
Performed to understand the physical and chemical
|| || || || || || ||
properties of a lead compound to enable the most
|| || || || || || || || ||
optimal formulation design
|| ||
Natural sources of Drugs:
|| || ||
, -Plants- the main source until the beginning of 20th
|| || || || || || || || ||
century
-Minerals
-Microorganisms
-Animals
Prodrugs:
A compound that requires metabolic biotransformation
|| || || || || ||
after administration to produce the desired
|| || || || || ||
pharmacologically active. ||
Typically designed to modify:
|| || ||
-Solubility
-Absorption
-Biostability
Questions With Answers || || ||
According to the FDA, New drug is defined:
|| || || || || || ||
Any drug that is NOT recognized as being safe and
|| || || || || || || || || ||
effective in the conditions recommended for its use in the
|| || || || || || || || ||
labeling among qualified experts
|| || || ||
A new chemical entity
|| || ||
A new formulation or method of manufacture of 'old
|| || || || || || || || ||
drug'
A new combination (including proportions) of two or
|| || || || || || || ||
more old drugs || ||
A new use/route of administration/dosage form for an
|| || || || || || || ||
established drug ||
,What is the approximate ratio of potential compounds
|| || || || || || || ||
that enters the drug development process to the number
|| || || || || || || || ||
of products that ultimately gets the FDA approval?
|| || || || || || ||
1:10,000
The science that deals with the adverse effects of drugs
|| || || || || || || || || ||
is known as:
|| ||
Toxicology
Preformulations Studies: ||
Performed to understand the physical and chemical
|| || || || || || ||
properties of a lead compound to enable the most
|| || || || || || || || ||
optimal formulation design
|| ||
Natural sources of Drugs:
|| || ||
, -Plants- the main source until the beginning of 20th
|| || || || || || || || ||
century
-Minerals
-Microorganisms
-Animals
Prodrugs:
A compound that requires metabolic biotransformation
|| || || || || ||
after administration to produce the desired
|| || || || || ||
pharmacologically active. ||
Typically designed to modify:
|| || ||
-Solubility
-Absorption
-Biostability
