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The U.
S.
FDA announced on May 14 that it would solicit comments on the clinical pharmacological evaluation of peptides.
The FDA expressed particular concern about the characterization of the effects of liver dysfunction, drug interactions, the pharmacokinetic immunogenicity of peptides, and the effects of peptides on cardiac electrophysiology.
But regarding peptide development, there may be other clinical pharmacological considerations.
S.
FDA announced on May 14 that it would solicit comments on the clinical pharmacological evaluation of peptides.
The FDA expressed particular concern about the characterization of the effects of liver dysfunction, drug interactions, the pharmacokinetic immunogenicity of peptides, and the effects of peptides on cardiac electrophysiology.
But regarding peptide development, there may be other clinical pharmacological considerations.
The U.
S.
FDA announced on May 14 that it would solicit comments on the clinical pharmacological evaluation of peptides.
The FDA expressed particular concern about the characterization of the effects of liver dysfunction, drug interactions, the pharmacokinetic immunogenicity of peptides, and the effects of peptides on cardiac electrophysiology.
But regarding peptide development, there may be other clinical pharmacological considerations.
The U.S.
FDA announced on May 14 that it would solicit comments on the clinical pharmacological evaluation of peptides.
The FDA expressed particular concern about the characterization of the effects of liver dysfunction, drug interactions, the pharmacokinetic immunogenicity of peptides, and the effects of peptides on cardiac electrophysiology.
But regarding peptide development, there may be other clinical pharmacological considerations.
S.
FDA announced on May 14 that it would solicit comments on the clinical pharmacological evaluation of peptides.
The FDA expressed particular concern about the characterization of the effects of liver dysfunction, drug interactions, the pharmacokinetic immunogenicity of peptides, and the effects of peptides on cardiac electrophysiology.
But regarding peptide development, there may be other clinical pharmacological considerations.
The FDA uses the term "peptide" to refer to polymers composed of 40 or fewer amino acids.
Peptides can be isolated from whole animal tissues, and can also be synthesized or recombinantly expressed in vitro to produce peptides.
Peptides are commonly used as signal molecules for many physiological functions regulated by endogenous proteins.
Peptides can exhibit different combinations of characteristics in terms of their chemistry, pharmacology, site of action, pharmacokinetic characteristics and pharmacodynamics.
Although the FDA has been monitoring peptides for decades, there is a growing need to design and perform clinical pharmacology studies to evaluate peptide-specific considerations, for example, studies designed to assess organ dysfunction or drug interactions.
At present, the FDA has not issued any clinical pharmacology evaluation guidance documents containing specific recommendations for peptides.
Peptides can be isolated from whole animal tissues, and can also be synthesized or recombinantly expressed in vitro to produce peptides.
Peptides are commonly used as signal molecules for many physiological functions regulated by endogenous proteins.
Peptides can exhibit different combinations of characteristics in terms of their chemistry, pharmacology, site of action, pharmacokinetic characteristics and pharmacodynamics.
Although the FDA has been monitoring peptides for decades, there is a growing need to design and perform clinical pharmacology studies to evaluate peptide-specific considerations, for example, studies designed to assess organ dysfunction or drug interactions.
At present, the FDA has not issued any clinical pharmacology evaluation guidance documents containing specific recommendations for peptides.
The FDA uses the term "peptide" to refer to polymers composed of 40 or fewer amino acids.
Peptides can be isolated from whole animal tissues, and can also be synthesized or recombinantly expressed in vitro to produce peptides.
Peptides are commonly used as signal molecules for many physiological functions regulated by endogenous proteins.
Peptides can exhibit different combinations of characteristics in terms of their chemistry, pharmacology, site of action, pharmacokinetic characteristics and pharmacodynamics.
Although the FDA has been monitoring peptides for decades, there is a growing need to design and perform clinical pharmacology studies to evaluate peptide-specific considerations, for example, studies designed to assess organ dysfunction or drug interactions.
At present, the FDA has not issued any clinical pharmacology evaluation guidance documents containing specific recommendations for peptides.
The FDA uses the term "peptide" to refer to polymers composed of 40 or fewer amino acids.Peptides can be isolated from whole animal tissues, and can also be synthesized or recombinantly expressed in vitro to produce peptides.
Peptides are commonly used as signal molecules for many physiological functions regulated by endogenous proteins.
Peptides can exhibit different combinations of characteristics in terms of their chemistry, pharmacology, site of action, pharmacokinetic characteristics and pharmacodynamics.
Although the FDA has been monitoring peptides for decades, there is a growing need to design and perform clinical pharmacology studies to evaluate peptide-specific considerations, for example, studies designed to assess organ dysfunction or drug interactions.
At present, the FDA has not issued any clinical pharmacology evaluation guidance documents containing specific recommendations for peptides.
Peptides can be isolated from whole animal tissues, and can also be synthesized or recombinantly expressed in vitro to produce peptides.
Peptides are commonly used as signal molecules for many physiological functions regulated by endogenous proteins.
Peptides can exhibit different combinations of characteristics in terms of their chemistry, pharmacology, site of action, pharmacokinetic characteristics and pharmacodynamics.
Although the FDA has been monitoring peptides for decades, there is a growing need to design and perform clinical pharmacology studies to evaluate peptide-specific considerations, for example, studies designed to assess organ dysfunction or drug interactions.
At present, the FDA has not issued any clinical pharmacology evaluation guidance documents containing specific recommendations for peptides.
The FDA invites interested parties to provide detailed information and opinions on certain aspects of the clinical pharmacology of the evaluation peptides.
The FDA recommends discussions based on the type of peptide (for example, isolated from animal sources or synthesized in vitro or produced by recombinant expression) and route of administration.
The FDA has raised some overall questions and hopes to get feedback:
The FDA recommends discussions based on the type of peptide (for example, isolated from animal sources or synthesized in vitro or produced by recombinant expression) and route of administration.
The FDA has raised some overall questions and hopes to get feedback:
The FDA invites interested parties to provide detailed information and opinions on certain aspects of the clinical pharmacology of the evaluation peptides.
The FDA recommends discussions based on the type of peptide (for example, isolated from animal sources or synthesized in vitro or produced by recombinant expression) and route of administration.
The FDA has raised some overall questions and hopes to get feedback:
The FDA invites interested parties to provide detailed information and opinions on certain aspects of the clinical pharmacology of the evaluation peptides. The FDA recommends discussions based on the type of peptide (for example, isolated from animal sources or synthesized in vitro or produced by recombinant expression) and route of administration.
The FDA has raised some overall questions and hopes to get feedback:
The FDA recommends discussions based on the type of peptide (for example, isolated from animal sources or synthesized in vitro or produced by recombinant expression) and route of administration.
The FDA has raised some overall questions and hopes to get feedback:
(1) Under what circumstances should the peptides be evaluated as follows?
(1) Under what circumstances should the peptides be evaluated as follows?
(1) Under what circumstances should the peptides be evaluated as follows?
(2) In the circumstances where the above assessment is required, which type of assessment is appropriate and why? What are the research design considerations for the evaluation types discussed in the following projects (for example, in vitro testing system, population, evaluation items, immunogenicity risk assessment, immunogenicity analysis development and validation)? Please describe the reasons for any design considerations proposed.
(2) In the circumstances where the above assessment is required, which type of assessment is appropriate and why? What are the research design considerations for the evaluation types discussed in the following projects (for example, in vitro testing system, population, evaluation items, immunogenicity risk assessment, immunogenicity analysis development and validation)? Please describe the reasons for any design considerations proposed.
(2) In the circumstances where the above assessment is required, which type of assessment is appropriate and why? What are the research design considerations for the evaluation types discussed in the following projects (for example, in vitro testing system, population, evaluation items, immunogenicity risk assessment, immunogenicity analysis development and validation)? Please describe the reasons for any design considerations proposed.
(a) To evaluate DDI based on pharmacokinetics (for example, in vitro studies, specialized clinical studies, including cocktail studies, population pharmacokinetic analysis), please discuss the advantages, challenges, and limitations of these evaluations.
(a) To evaluate DDI based on pharmacokinetics (for example, in vitro studies, specialized clinical studies, including cocktail studies, population pharmacokinetic analysis), please discuss the advantages, challenges, and limitations of these evaluations.
(a) To evaluate DDI based on pharmacokinetics (for example, in vitro studies, specialized clinical studies, including cocktail studies, population pharmacokinetic analysis), please discuss the advantages, challenges, and limitations of these evaluations.
(b) In order to evaluate the pharmacokinetics of liver insufficiency (for example, specialized clinical studies, population pharmacokinetic analysis), please discuss the advantages, challenges, and limitations of these evaluations.
(b) In order to evaluate the pharmacokinetics of liver insufficiency (for example, specialized clinical studies, population pharmacokinetic analysis), please discuss the advantages, challenges, and limitations of these evaluations.
(b) In order to evaluate the pharmacokinetics of liver insufficiency (for example, specialized clinical studies, population pharmacokinetic analysis), please discuss the advantages, challenges, and limitations of these evaluations.
(c) To evaluate immunogenicity and its influence on pharmacokinetics, safety and effectiveness (for example, antibodies against active ingredient peptides, peptide-related impurities or endogenous counterparts (if any), neutralizing activity And antibody titers, cytokine determination), please discuss the advantages, challenges and limitations of these evaluations.
(c) To evaluate immunogenicity and its influence on pharmacokinetics, safety and effectiveness (for example, antibodies against active ingredient peptides, peptide-related impurities or endogenous counterparts (if any), neutralizing activity And antibody titers, cytokine determination), please discuss the advantages, challenges and limitations of these evaluations.
(c) To evaluate immunogenicity and its influence on pharmacokinetics, safety and effectiveness (for example, antibodies against active ingredient peptides, peptide-related impurities or endogenous counterparts (if any), neutralizing activity And antibody titers, cytokine determination), please discuss the advantages, challenges and limitations of these evaluations.
(d) To evaluate cardiac electrophysiology in non-clinical or clinical studies (eg, hERG inhibition assays, comprehensive QT evaluations), please discuss the advantages, challenges, and limitations of these evaluations.
(d) To evaluate cardiac electrophysiology in non-clinical or clinical studies (eg, hERG inhibition assays, comprehensive QT evaluations), please discuss the advantages, challenges, and limitations of these evaluations.
(d) To evaluate cardiac electrophysiology in non-clinical or clinical studies (eg, hERG inhibition assays, comprehensive QT evaluations), please discuss the advantages, challenges, and limitations of these evaluations.
(3) Are there other clinical pharmacological considerations for peptides not covered by the above questions, such as the use of pharmacokinetic biomarkers and/or pharmacokinetic evaluation for dose selection? If so, please provide a description and reasons for any proposed consideration, as well as evaluation methods, advantages, challenges and limitations.
(3) Are there other clinical pharmacological considerations for peptides not covered by the above questions, such as the use of pharmacokinetic biomarkers and/or pharmacokinetic evaluation for dose selection? If so, please provide a description and reasons for any proposed consideration, as well as evaluation methods, advantages, challenges and limitations.
(3) Are there other clinical pharmacological considerations for peptides not covered by the above questions, such as the use of pharmacokinetic biomarkers and/or pharmacokinetic evaluation for dose selection? If so, please provide a description and reasons for any proposed consideration, as well as evaluation methods, advantages, challenges and limitations.
The FDA stated that the collected public comments will help the FDA formulate recommendations on the design and execution of clinical pharmacology studies.
These recommendations are very important for understanding the safe and effective use of peptides, and contribute to the regulatory evaluation of such studies.
Interested parties can log on to to submit comments.
The deadline is July 13, 2021.
These recommendations are very important for understanding the safe and effective use of peptides, and contribute to the regulatory evaluation of such studies.
Interested parties can log on to to submit comments.
The deadline is July 13, 2021.
The FDA stated that the collected public comments will help the FDA formulate recommendations on the design and execution of clinical pharmacology studies.
These recommendations are very important for understanding the safe and effective use of peptides, and contribute to the regulatory evaluation of such studies.
Interested parties can log on to to submit comments.
The deadline is July 13, 2021.
The FDA stated that the collected public comments will help the FDA formulate recommendations on the design and execution of clinical pharmacology studies. These recommendations are very important for understanding the safe and effective use of peptides, and contribute to the regulatory evaluation of such studies.
Interested parties can log on to to submit comments.
The deadline is July 13, 2021.
These recommendations are very important for understanding the safe and effective use of peptides, and contribute to the regulatory evaluation of such studies.
Interested parties can log on to to submit comments.
The deadline is July 13, 2021.
Author: Zhilin-Lanshan
Author: Zhilin-Lanshan
Author: Zhilin-Lanshan 
