Good Clinical Practices & 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 GCP 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.

GCP follows the International Conference on Harmonization (ICH) guidelines. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. These standards for clinical trials are sometimes referred to as ICH-GCP. OECD guidelines for the testing of chemicals are used for studies involving in vitro test systems to obtain data on the safety of chemicals with respect to human health and the environment. SAS Programming is used to allow clinical trial statisticians to perform their statistical analysis duties more efficiently. Clinical Trials are used to confirm the efficacy and safety of the drug, which is in the trial stage, on human population.

  • 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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