Pre-Publication draft version. Lat reviewed on 7th July 2017
These guidelines are applicable to all biomedical, social and behavioural science research for health conducted in India involving human participants, their biological material and data.
The purpose of such research should be: i. directed towards enhancing knowledge about the human condition while ...maintaining sensitivity to the Indian cultural, social and natural environment; ii. conducted under conditions such that no person or persons become mere means for the betterment of others and that human beings who are participating in any biomedical and/or health research or scientific experimentation are dealt with in a manner conducive to and consistent with their dignity and well-being, under conditions of professional fair treatment and transparency; and iii. subjected to a regime of evaluation at all stages of the research, such as design, conduct and reporting of the results thereof.
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In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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Pathak et al. (2016), PeerJ, DOI 10.7717/peerj.1738; 1-14
Towards ending tuberculosis and multidrug-resistant tuberculosis.
DHS Working Papers No. 125
PQDx 0033-013-00 WHO
PQ Public Report
July/2016, version 5.0
12-13 December 2016
Global Action Plan on HIV Drug Resistance - Webinars 12-13 December 2016
The use of Delamanid and Bedaquiline for Children with Drug-Resistant Tuberculosis.
Guidelines
Key Populations
2016 Update
Key population