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Institute of Pharmaceutical and Environmental Research (IPER)
 

Introduction
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Preface
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Vision & Mission
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Objectives
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Intro to the medical and clinical research

 

A BACKGROUND

The parameters of life are now being transformed into specialties in nearly all areas of human culture, be it the physical state in health or disease, or mental approaches, the emotional being of every human of all ages and both sexes, or societal and spiritual aspects of human norms and values.

 

Health has always been the priority in making and developing policies in all societies of world regardless of religion, culture, color, casts and language. World was transformed in many areas after the huge threatened disasters and miseries of World War II, 1939-1945. World Health Organizations (WHO), established in 1948 took respectable steps to assign the global equity addressing for general health and needs of common man and women, children, old and young adults, healthy or diseased people in all of its agendas. This leads to modify and simplify the search for better and early diagnosis, investigation and treatment through continuous research, and launching of the International Conference of

 

Harmonization (ICH) for ensuring Good Clinical Practices (GCP) in new studies as ICH/GCP guidelines.

 

Through this platform, the new drug application in Food and Drug Administration (FDA), US, became safe and new advance formula therapies became more visible and accessible to the common public.

 

Since the inception of ICH/GCP in 1990, for the uniformity and harmonization of clinical research in the field of pharmaceuticals, human life arrived at safe and steady state in getting involve in research studies of medical science, or medical & clinical research, at all phases, phase I-IV, preclinical stage/early stage or laboratory research studies, and bioavailability/bioequivalence studies.

 

The life science world, comprising pharmaceutical, bio pharmaceutical, biotechnology and medical device companies played vital and front line role in proceeding toward the new borders of the clinical research industry, along with the giants of the Asia Pacific region, India, China and Australia.

 

Clinical research was outsourced towards three major areas as emerging markets, first LATAM, Latin America, second MENA, Middle East and North Africa with Eastern Europe, third South Asia and Asia Pacific.

 

In last decade of years 2000-2011, followed a big flow of clinical studies at the third emerging markets, region of South Asia, as India and China supersedes in getting most of the studies to run under their home sites and at their newly established organizations, Clinical & Contract Research Organizations (CRO) and Site Management Organization (SMOs). With the pharmaceutical companies, who take the lead in running clinical and bioequivalence studies, these research organization provided specialized services to manage and support the studies in difficult conditions, economical charges, sufficient patient pool, complying with ICH/GCP guidelines with study specific and Standard Operative Procedure (SOP) based training of professional staff.

 

As Pakistan is always with the international platforms of all life aspects for the betterment of mankind, in this area of clinical research it identified its highly skilled and qualified personnel, to utilize it&rsquos resources as well as intellectual manpower and in the proper and appropriate execution of research studies in all big cities of nation, Karachi, Lahore, Islamabad, Quetta, and Peshawer.

 

The CROs and SMOs of Pakistan worked in all areas of clinical research, providing a big structure of highly skilled clinical research professionals, as well as certified with the training from abroad institute affiliated with these research organizations.

These professionals, C.C.R.Ps proved to be the professionals of international standards, monitoring and managing international studies.

Pakistan leading universities, Bahria University Karachi, Dow University of Health Sciences (DUHS), Karachi and Liaqat University of Medial & Health Sciences (LUMHS), Jamshoro, Sindh, collaborated for these studies with such life sciences sector for the national growth, providing the training centers and independent departments and institutes for the scientists and their co-workers.

 

Dow University of Health Sciences, Ojha campus, Karachi is involved in the execution of clinical phase trials at its Clinical Trial Unit, Phase II-IV and established its Bio-availability and Bio-equivalence (BA/BE) study center at Institute of Pharmaceutical & Environmental Research (IPER).

 

BA/BE studies are quite different from clinical phase trails from being short duration, non-critical and mostly conducted with the involvement and enrollment of healthy individuals of an active stage, between ages of 18 to 55 years.