Even before a drug could be tested in a clinical trial, the development process of a drug generally involves three major steps, including discovery, preclinical development, and then clinical trial. The transition from discovery to preclinical development is an ongoing process. The results obtained from toxicology and preliminary pharmacology testing often contribute to candidate selection for a drug. The filing of an Investigational New Drug (IND) sets up a boundary between preclinical development and Clinical Research Courses of of a drug.
The following international organizations ensure drug safety and efficacy:
- World Health Organization (WHO),
- Pharmaceutical Inspection Co-operation Scheme (PIC/S),
- International Organization for Standardization (ISO),
- International Conference on Harmonization (ICH),
- Parenteral Drug Association (PDA), and
- International Society for Pharmaceutical Engineering (ISPE).
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Some of the national regulatory bodies issuing guidelines for drug development include:
- European Medicines Evaluation Agency (EMEA), Europe
- Food and Drug Administration (FDA), US
- Regulatory Operations and Enforcement Branch of Health Canada (ROEB), Canada
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
- Medicines and Healthcare products Regulatory Agency (MHRA), UK
- Brazilian Health Regulatory Agency (ANVISA), Brazil
- Therapeutic Goods Administration (TGA), Australia
- Turkish Medicines and Medical Devices Agency (TMMDA), Turkey
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Al-Farabi Kazakh National University, located in Almaty, Kazakhstan, is the largest in the country.
The Al-Farabi Kazakh National University is one of the most preferred universities of the nation.
The soviet system found the university, which makes it a centralized university, and therefore it is a government university.
The Al-Farabi Kazakh National University offers several courses along with other degree courses in post-graduation and Ph.D.
It is the most preferred university for MBBS in Kazakhstan.
Many international organizations such as the WHO and the MCI have recognized the Al-Farabi Kazakh National University, which means Indian students can legally practice medicine in India after attaining the degree from this university.
Biocompatibility testing and evaluations for medical devices is a vital component of patient safety, for it is the only effective means to ensuring that a medical device or any related material, when it happens to come into contact with the patient's body has to not only perform its intended purpose and function; it should also not result in adverse reactions for the patient.
When medical devices and/or materials come into contact with the patient's body, they can cause problems or what may be termed adverse effects that can be either short-term or long-term adverse effects to the body.
These effects, called acute to chronic, can result in mutagenic effects.
It is to prevent the occurrence of such events that biocompatibility testing and evaluations for medical devices has to be carried out.
These evaluations for biocompatibility of medical devices are done to evaluate the interaction between a device and anything it comes into contact with within the patient's body, such as cells, tissue or body fluids.
Essentially, device biocompatibility is assessed to prevent biological risks from happening to the patient.
