Guidelines for Good Clinical Laboratory Practices (GCLP) outlines the principles and procedures to be followed by medical laboratories involved in clinical research and/or patient care so as to prov
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ide quality data which can be used for health research and patient treatment. As the use of laboratory tests (often expensive) are increasingly becoming a part of medical diagnosis and research, generation of quality data would be a cost-effective and ethically sound strategy.
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The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells
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of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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This publication is based on the list of clinical interventions selected from clinical guidelines on prevention, screening, diagnosis, treatment, palliative care, monitoring and end of life care. Th
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is publication addresses medical devices for six types of cancer: breast, cervical, colorectal, leukemia, lung and prostate. The first section defines the global increase in cancer cases, the global goals to manage NCDs and the WHO activities related to these goals. The second section presents the methodology used for the selection of medical devices that support clinical interventions required to screen, diagnose, treat and monitor cancer stages, as well as the provision of palliative care, based on evidence-based information. The third section lists the priority medical devices required to manage cancer in seven different units of health care services: 1. Vaccination, clinical assessment and endoscopy, 2. Medical imaging and nuclear medicine, 3. Surgery, 4. Laboratory and pathology, 5. Radiotherapy, 6. Systemic therapy and 7. Palliative and end of life care
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The updated List of Essential Diagnostics contains 46 general tests that can be used for routine patient care as well as for the detection and diagnosis of a wide array of disease conditions, and 69 tests intended for the detection, diagnosis and monitoring of specific diseases.
The List is divid
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ed into two sections depending on the user and setting: one for community settings, which includes self-testing; and a second one for clinical laboratories, which can be general and specialized facilities.
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Diabetes mellitus, also called diabetes, is a chronic metabolic condition in which the hormone insulin is not produced by the
pancreas in sufficient quantities or is not utilized effectively by the body to control blood glucose levels. As a result, blood
glucose levels are abnormally high (hypergl
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ycaemia). Chronic uncontrolled hyperglycemia leads to long-term target organ damage, such as: retinopathy, nephropathy and neuropathy (microvascular complications); stroke, coronary heart disease
and peripheral arterial disease (macrovascular complications).
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This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospita
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ls in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included.
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These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutical products in Rwanda. It was compiled by the Technical Working Group (TWG) on Medicines Evaluation and Registration (MER) of the East African Community M
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edicine Regulatory Harmonization (EAC MRH) Project. The group relied on their experiences and knowledge on medicines registration requirements of their individual Countries. World Health Organization (WHO) and the International Conference on Harmonization of Technical Requirements of Medicines for Human Use (ICH) and other available literature.
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This update of the Guidelines for poison control, entitled Guidelines for establishing a poison centre, reflects the development of the role of poison centres in public health and the sound management of chemicals, described in section 1, and the opportunities provided by new technology. Assessments
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carried out under the IHR show
continuing gaps in capacity for managing chemicals (2). In particular, many countries still lack access to poison
centre services (3). There is therefore demand for updated guidance.
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Front Chem. 2021; 9: 622286.
Published online 2021 Mar 12. doi: 10.3389/fchem.2021.622286
Up-to-date Literature review current through: Jan 2015. | This topic last updated: Jan 29, 2015.