This is a general category for clinical research
Pre-clinical drug development process is a risk based process that involves safety and efficacy evaluation of drugs in animal species that extrapolate to potential human outcome. The pre-clinical pharmacologic and toxicological drug responses with respect to dose regimen and route of administration enable to initiate and continue research in human beings. In general, pre-clinical studies […]
For some strange reason, training looks like an unattractive offering, but in reality it is essential for every Sponsor/CRO conducting a trial, to offer ample training to their clinical trial site staff where the clinical trial would be conducted. What is Study Specific Training? Study Specific Training generally refers to training which is specific to […]
NDM-1 is a gene known as “New Delhi metallo-beta-lactamase-1”, which gives certain kind of bacteria the ability to produce an enzyme called carbapenemase that renders resistance to broad range of β-lactum antibiotics. These include the antibiotics of Carbapenem family, also known as antibiotics of last resort, along with Penicillin and Cephalosporin. NDM-1 was first identified […]
We have all been talking about ethics related to patient safety, informed consent, ethics committees etc; however not much is talked about publishing of the data that comes out of every research, be it preclinical or clinical. The question is: Are research results published ethically? History tells us that when it comes to publishing of […]
Behaving ethically is now-a-days being considered as an easy to deal task by every researcher. Ask any researcher about ethics and the reply you will get casually is that ‘I am doing the right thing and yes I am following ethics’; whilst the things in many cases run in real different fashion. It has always […]
Large number of hospitals, well qualified and experienced doctors, very huge patient pool emblematizing chronic as well as infectious diseases, high cost saving and easy patient recruitment is leading India to become a lucrative hub for conducting global clinical trials. The reduced cost of conducting clinical trials in India as compared to other parts of […]
DOWNLOAD Schedule Y HERE Schedule Y, the current regulator (CDSCO – Central Drugs Standard Control Organization) enforced law in India has been established under Drugs and Cosmetic Act 1945. The regulations to be followed when conducting clinical trials in India are clearly documented to a large extent in this document. Schedule Y for India is […]
Clinical Trials are generally considered to be biomedical or health related research studies in human beings that follow a pre-defined protocol. Statistics say that only one molecule out of 5000 new discoveries reach the pharmacist shelf after undergoing various evaluation phases. Every new chemical entity discovered must pass through all the phases of clinical trials […]
UAE (United Arab Emirates) is attracting a newer Industry like clinical trials to its base and is creating a paradigm shift from the developing countries. This shift has been slow paced, yet remarkable. The scenario was initiated with top 10 pharmaceutical companies establishing themselves in this region and making their presence felt. Following this the […]
Cancer is one of the leading cause of death in today’s world just secondary behind heart disease. According to Rafael Bengoa, director of management of chronic disease at the World Health Organization, 15 to 16 million new cases of cancer emerge every year. Cancerous cells are continuously dividing and multiplying cells that invade tissues and […]