National Institute of Pharmaceutical Education and Research (NIPER) is the first national level institute in pharmaceutical sciences with a proclaimed objective of becoming a centre of excellence for advanced studies and research in pharmaceutical sciences. The Government of India has declared NIPER as an ‘Institute of National Importance’. It is an autonomous body set up under the aegis of Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India. The Institute is conceived to provide leadership in pharmaceutical sciences and related areas not only within the country, but also to the countries in South East Asia, South Asia and Africa.

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Bioinformatics Institute of India (BII), set-up in the year 2002 has acquired international reputation by conducting industry oriented knowledge enhancement programs in the emerging domains of life science. BII was established by the prestigious Confrere Educational Society. Within a short span of a decade, BII has traversed many milestones in academic excellence and is today recognized as premier institute for providing the training in the area of Bioinformatics, Biotechnology, Pharma, Clinical Trials etc. The course-curriculum has been designed on global industrial pattern to fill the gap between academia and industry has lead BII to attain professional expertise in the field of life science and its allied area.

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In October 1990 the B. V. Patel Education Trust in conjuncture with the Indian Pharmaceutical Association established B. V. Patel Pharmaceutical Education & Research Development (PERD) Centre, in the memory of late Mr. B. V. Patel, the first Drug Controller of Gujarat.
Started with the express aim of providing the Pharmaceutical industry and academia the opportunity and resources to undertake the latest in research and development, PERD Centre is India's first multidisciplinary, postgraduate research institute, promoting advanced research, services and training in the field of pharmaceutical sciences.

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Indian Institute of Chemical Technology, Hyderabad is a premier R&D Institute in India. The Institute had its origin as the Central Laboratories for Scientific & Industrial Research (CLSIR), established in 1944 by the then Government of Hyderabad State. After integration of Hyderabad State with the Indian Union, the laboratory expanded with its growing activities. The main building was formally opened by Pandit Jawaharlal Nehru, the then Prime Minister of India on January 2, 1954. In 1956, the Central Laboratories came under the aegis of the Council of Scientific & Industrial Research (CSIR), New Delhi and was renamed Regional Research Laboratory, Hyderabad (RRL-H).

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The Indian Institute of Toxicology Research (IITR), Lucknow, a premier institute under the Council of Scientific and Industrial Research (CSIR) is involved in multidisciplinary R&D programmes of both basic and applied nature across scientific disciplines for economic, environmental and societal benefits for the people of India. IITR, Lucknow engaged in the areas of Environmental Toxicology, Food, drug and chemical toxicology , Systems Toxicology & Health Risk Assessment, Regulatory toxicology, Nanotherapeutics & Nanomaterial Toxicology and also National S&T Missions. IITR has two campuses; the main campus is located at the centre of Lucknow City and the other campus at a distance of approx.

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The ICGEB is an international, nonprofit research organization. Established as a special project of UNIDO, it became fully autonomous in 1994 and now counts over 60 Member States.
The International Centre for Genetic Engineering and Biotechnology provides a scientific and educational environment of the highest standard and conducts innovative research in life sciences for the benefit of developing countries. It strengthens the research capability of its Members through training and funding programmes and advisory services and represents a comprehensive approach to promoting biotechnology internationally.

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Agharkar Research Institute (ARI) is an autonomous, grant-in-aid research institute of the Department of Science and Technology (DST), Goverment of India. It was established in 1946 by the Maharashtra Association for the Cultivation of Science as MACS Research Institute and renamed as ARI in 1992 in honour and memory of its founder Director, late Professor S.P. Agharkar.

Post: Research Associate, Junior Research Fellow

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Maynor Consulting, International Pharmaceutical Company

Post: Medical Advisor-2

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ABOUT AUTHORS:
MR. Gunjegaonkar S.M., MR. Shelke T.T.
Assistance Professor.
Dept. of Pharmacology JSPM’s Charak College of Pharmacy and research,
Wagholi, Pune. Maharashtra.
*gunjeshiv@gmail.com

Internal audit is designed programme to seek any short comings in quality assurance systems and to suggest corrective action. It also monitors implementation and compliance with current good manufacturing practices.

A.OBJECTIVES:
1. Ensure  that  companies  operations  remain  compliance  with  and  implements  cGMP.
2. Assist in ensuring continuous quality improvement.
3. Cover all corrective aspects in production and quality control.

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ABOUT AUTHOR:
Raj Kishor
Avigna Clinical Research Institute
Bangalore, India
raryan859@gmail.com

ABSTRACT
The pharmacologic treatment of hypertension (HT) has been extensively studied by clinical trials. These studies have provided definitive evidence of treatment benefit and the weight and consistency of the clinical evidence has lead to uniformity in many aspects of treatment recommendations worldwide. The international guidelines and current clinical and biostatistical practices were reviewed for relevant clinical, design, end-point assessments and regulatory issues. The results are grouped mainly into ethical, protocol and assessment issues. Ethical issues arise as placebo-controlled trials (PCTs) for HT-lowering agents in patients with moderate to severe HT are undertaken. Patients with organ damage due to HT should not be included in long-term PCT. Active-control trials, however, are suitable for all randomized subsets of patients, including men and women, and different ethnic and age groups. Severity subgroups must be studied separately with consideration to specific study design. Safety studies must be very vigilant on hypotension, orthostatic hypotension and effects on heart. In dose-response studies, at least three doses in addition to placebo should be used to well characterize the benefits and side-effects. Mortality and morbidity outcome studies are not required in anti-HT trials except when significant mortality and cardiovascular morbidity are suspected. Generally, changes in both systolic and diastolic blood pressures (BP) at the end of the dosing interval from the baseline are compared between the active and the control arms as the primary endpoint of anti-HT effect.

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