Good Clinical Practices and Good Laboratory Practices

The role of ICH in designing GCP principles is to provide an ethical treatment to the subjects who are involved in the clinical trials. Conference on Good Clinical Practices is important because it is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. The GLP Principles describe requirements for and provide general guidance on the conduct of all nonclinical health and environmental safety studies, including invitro studies. Pre-clinical trials assess the toxicity of a drug and examine its potential effects on the human body. These trials are conducted in-vitro which is required to proceed with clinical trials. Good laboratory practices should be followed for these pre-clinical trials.

 

  • Role of ICH in designing GCP principles
  • Principles of GLP in vitro Studies
  • OECD guidelines for the testing of chemicals
  • Good Laboratory Practices (GLP) for Pre-Clinical Testing
  • IEC-GCP regulations
  • Pre-clinical trails
  • Clinical trails
  • SAS programming, usage in pharmaceutical industry

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