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TDM Laboratory
 

TAKING OFF

The establishment of the Therapeutic Drug Monitoring Laboratory was another significant addition to the S P Mandali's enviable record of being a pioneer in the field of higher education and research. The laboratory was inaugurated on 19th August 1986 by Mr. Sushilkumar Shinde, the then Minister for Finance, Maharashtra State. It was a historic event : another manifestation of the S P Mandali's firm commitment to academic excellence, self-reliance and the promotion of indigenous research and development.

EXACTING STANDARDS

The Therapeutic Drug Monitoring laboratory offers facilities for monitoring the bioavailability, comparative bioavailability and bioequivalance of therapeutic drugs. In so far as bioavailability is the amount of the drug is available in the blood over a particular period of time, it is a determinant of the drug's safety. If two products have statistically similar bioavailability, they are said to be "bioequivalent"; and can be substituted for each other. The laboratory also has facilities for the analysis of synthetic drug and drug intermediates from pharmaceutical preparations by chemical, instrumental, microbiological and biological methods. Healthy volunteers who help in the assessment of the efficacy and safety of new drugs are drawn from various localities, colleges and universities; they are carefully screened and assessed by experts to ensure that they meet all requisite criteria. The entire laboratory setup satisfies all the requirements laid down in the proposed international guidelines for biomedical research involving human subjects issued by the World Health Organization and the Council for International Organization of Medical Sciences in 1982, and the policy statement on ethical considerations involved in research on human subjects issued by the Indian Council of Medical Research in 1980.

HUMAN RESOURCES & TRAINING

Employee-training is an integral part of a laboratory's commitment to quality and to consistency in its performance. A dedicated team of highly qualified professionals formulates and offers perceptive instructional programmes that enhance the competence and efficiency of the laboratory's personnel

INFRASTRUCTURE

The laboratory is housed in a two-storey building. A cold-storage room, a clinical pharmacological unit (CPU), a documentation room, a gas-cylinder room, and the offices of the honorary director, assistant director, technical manager, quality manager and the assistant technical manager are all located on the ground floor.

The first floor houses the analytical complex which comprises two instrumental laboratories, a microbiological laboratory, a sample-preparation room, a wet chemistry laboratory, and a distillation-unit room. A kitchen, a store-room and the accounts office are also accommodated on the first floor.

On the second floor, the TDM has a commodious seminar room and a spacious library which houses and excellent collection of reference books. The TDM library has a direct link with more than 250 data bases all over the world through a 'Dialogue-System' network and the STN network; it is also adequately stocked with chromatography-related interactive software acquired from the Royal Chemical Society and E. Merck Limited. Augmenting the TDM's valuable stock of information are extensive volunteer data bases that play a very important role in the studies conducted by it.
 

EQUIPMENT

The three top slots in the hierarchical ladder are occupied by the Honorary Director, the Assistant Director and the Technical Manager who play a key role in the general administration and functioning of the TDML. In addition to these, the laboratory has a highly competent managerial staff invested with the authority and resources that are needed to encourage its performance at the highest levels of efficiency.

The laboratory functions as a non-profitmaking unit under the guidance and supervision of an ethical review committee and a local managing committee. On the ethical review committee are leading clinicians, pharmacologists, social workers, educationists and legal advisors.
 

LOOKING AHEAD

Indian and foreign pharmaceutical concerns can now get their drugs meticulously tested for safety. They can also get their bioequivalance analysed in relation to leading international brands. Drugs which clear this step will measure up to the finest international standards and will make a substantial addition to our exports. Moreover, in the long run, the expertise of scientists, who have been trained in the laboratory, will be made accessible to industry.

For more information on TDM laboratories please visit the following url :
http://www.tdmlab.com/

 

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Copyright © 2006 Ramnarain Ruia College

Last modified: December 18, 2006
 

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