1.5.6 Manufacturing of Biomaterials
Once the final effective component’s efficacy and safety have been ensured, the next
step is manufacturing. The most important step in the manufacturing design process
is assessment of the effective component’s characteristics, including its physical,
chemical, and biological properties. Biological properties to be tested include
pharmacology, efficacy, affected regions, dosage, blood concentration, absorption
distribution, absorption regions, absorption rate, metabolism and excretion, biological half-life, and side effects. Physical properties to be tested include solubility
and safety. Once the medicine has been produced, its characteristics are assessed.
Areas included in this assessment are biological characteristics (absorption and
excretion), sensory characteristics (taste, smell, and color), physiochemical characteristics, longitudinal safety, and the presence of foreign matter and microbe
contaminants. After the medicine’s characteristics have been assessed, the production process begins, and a final assessment is made on the experimental product,
including clinical product.
1.5.7 Clinical Testing of the Final Product
Once pre-clinical testing of toxicity and pharmacology has been completed and a
permit has been issued by the Minister of Health and Welfare, production manufacturing approval for clinical testing is received and a clinical product is manufactured. Clinical testing follows designated guidelines: safety is demonstrated
through pre-clinical testing, and a trial drug that is expected to have clinical efficacy
is used in three phases of, I, II and III, testing.
In the first testing phase, the trial drug is given to a human subject and examined
for the first time based on the pre-clinical test results. A healthy subject is used to
confirm the drug’s safety, and safe amounts and maximum permissible doses are
estimated to provide data for the second phase of testing. Pharmacokinetic research
is also conducted for the drug to collect basic data on its absorption, metabolism,
and excretion.
In the second testing phase, the trial drug is administered to patients for the first
time to verify its efficacy and safety and examine its pharmacokinetic effects.
Dosage quantities, intervals, and period are determined for the third phase of
testing.
In the third testing phase, quantity and usage findings from the efficacy and
safety testing of the trial drug in the second stage are used for an expanded range of
clinic testing subjects in order to affirm the drug’s effects and safety and identity any
infrequent side effects. The final goal is to establish efficacy, effects, usage methods
and amounts, and any areas for caution in view of the effectiveness and safety of the
trial drug.
1.5 Developing Industries with New Marine Biotechnology Materials
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Once the final effective component’s efficacy and safety have been ensured, the next
step is manufacturing. The most important step in the manufacturing design process
is assessment of the effective component’s characteristics, including its physical,
chemical, and biological properties. Biological properties to be tested include
pharmacology, efficacy, affected regions, dosage, blood concentration, absorption
distribution, absorption regions, absorption rate, metabolism and excretion, biological half-life, and side effects. Physical properties to be tested include solubility
and safety. Once the medicine has been produced, its characteristics are assessed.
Areas included in this assessment are biological characteristics (absorption and
excretion), sensory characteristics (taste, smell, and color), physiochemical characteristics, longitudinal safety, and the presence of foreign matter and microbe
contaminants. After the medicine’s characteristics have been assessed, the production process begins, and a final assessment is made on the experimental product,
including clinical product.
1.5.7 Clinical Testing of the Final Product
Once pre-clinical testing of toxicity and pharmacology has been completed and a
permit has been issued by the Minister of Health and Welfare, production manufacturing approval for clinical testing is received and a clinical product is manufactured. Clinical testing follows designated guidelines: safety is demonstrated
through pre-clinical testing, and a trial drug that is expected to have clinical efficacy
is used in three phases of, I, II and III, testing.
In the first testing phase, the trial drug is given to a human subject and examined
for the first time based on the pre-clinical test results. A healthy subject is used to
confirm the drug’s safety, and safe amounts and maximum permissible doses are
estimated to provide data for the second phase of testing. Pharmacokinetic research
is also conducted for the drug to collect basic data on its absorption, metabolism,
and excretion.
In the second testing phase, the trial drug is administered to patients for the first
time to verify its efficacy and safety and examine its pharmacokinetic effects.
Dosage quantities, intervals, and period are determined for the third phase of
testing.
In the third testing phase, quantity and usage findings from the efficacy and
safety testing of the trial drug in the second stage are used for an expanded range of
clinic testing subjects in order to affirm the drug’s effects and safety and identity any
infrequent side effects. The final goal is to establish efficacy, effects, usage methods
and amounts, and any areas for caution in view of the effectiveness and safety of the
trial drug.
1.5 Developing Industries with New Marine Biotechnology Materials
19