How to know about ICH Guidelines Part 2.
We are discussing about ICH Guidelines part-2.
The International Conference on Hormonisation of techinical requirments for registration of pharmaceuticals for human use.
Since its inception in 1990, ICH has gradually evolved to respond to the incresingly global face of drug development.
The ICH guidelines are explained in 4 different topics, those are 1.Quality topics
2.Safety topics
3.Efficacy topics
4.Multi disciplinary topics.
The work carried out by ICH under the Efficacy heading is concerned with design, conduct, safety and reporting of clinical
trials.
The clinical trials are two types, those are pre-clinical trials and clinical trails.
The pre-clinical trials are carried throughout the animals, after its succeed it will entered in human body and it is
commonly called as clinical trials.
It is also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics or
pharmacogenomics techniques to produce better targeted medicines.
These are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories.
It includes the ICH medical terminology, it is commonly called as Medical Dictionary for Regulatory Affairs(MedDRA).
The Common Technical Document(CTD) is a document, it is a registration of medicines, and it is used for to design and
structure of the medicines.
The Electronic Common Technical Document(ECTD) is a format, and it is the standard format for submitting applications,
amendaments, suppliments and reports to FDA.
The International Conference on Hormonisation of techinical requirments for registration of pharmaceuticals for human use.
Since its inception in 1990, ICH has gradually evolved to respond to the incresingly global face of drug development.
The ICH guidelines are explained in 4 different topics, those are 1.Quality topics
2.Safety topics
3.Efficacy topics
4.Multi disciplinary topics.
The work carried out by ICH under the Efficacy heading is concerned with design, conduct, safety and reporting of clinical
trials.
The clinical trials are two types, those are pre-clinical trials and clinical trails.
The pre-clinical trials are carried throughout the animals, after its succeed it will entered in human body and it is
commonly called as clinical trials.
It is also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics or
pharmacogenomics techniques to produce better targeted medicines.
These are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories.
It includes the ICH medical terminology, it is commonly called as Medical Dictionary for Regulatory Affairs(MedDRA).
The Common Technical Document(CTD) is a document, it is a registration of medicines, and it is used for to design and
structure of the medicines.
The Electronic Common Technical Document(ECTD) is a format, and it is the standard format for submitting applications,
amendaments, suppliments and reports to FDA.
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