Innovative and Adaptive Designs in Clinical Studies

The Food and Drug Administration (FDA) had noted a decreased number of submissions for new drugs in 2004. This had raised FDA concern as pharmaceutical companies were slowly abandoning research for potentially life-saving drugs. The decreased interest of companies...

Challenges and Emerging Opportunities in Cancer

Cancer is a condition in which the abnormal cells start to grow uncontrollably with the potential to destroy healthy tissues of the body. It is the 2nd leading cause of death in the world; about 1 in 6 deaths is due to cancer. However, no specific cause has been...

Interpretation of Pharmacovigilance Regulations

Pharmacovigilance (PV) or drug safety is defined as the science and activities that are related to the collection, detection, assessment, monitoring and prevention of side effects (ie adverse drug reactions [ADRs]) of the marketed drugs. The safety information about...

An Update on Regulatory Electronic Submission

The Federal Food, Drug, and Cosmetic Act (FD&C) has enacted a law under Section 745A(a) that the regulatory submissions including investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics...

Virtual Clinical Studies

Many clinical studies fail at the initial stages of the study as enough volunteers do not participate in the planned period of the study or most of the volunteers drop out before the end of the study. These issues can be solved to a great extent by conducting a...

Ocular Disease and Drug Development

Ocular or eye disease is a condition that can result in either complete loss of vision or in blurred vision. This can be major or minor and adversely affects the quality of life in both cases. Approximately 80% of eye diseases are caused by inherited defects. The...

Outsourcing in Clinical Operations

Necessity of Outsourcing The drug development is a highly complex and time-consuming process. This puts restrictions on the Sponsor in dealing with the increased workload adequately. In clinical operations, the Sponsor may require outsourcing services for different...

Informal Communications with Regulatory Agencies

The formal meetings between the regulators and the applicant or sponsor occur at various phases of drug development. Before conducting such meetings, there should be an adequate basis for the need of meeting. Sometimes these meeting can be refused if the regulator...

Hemophilia: Causes, Symptoms & Diagnosis

World Hemophilia Day is held annually on April 17th to increase the awareness of haemophilia and other bleeding disorders. Hemophilia is a rare bleeding disorder in which the blood doesn't clot normally. People suffering from hemophilia have insufficient blood...

Things to know about Breast Cancer

After lung cancer, breast cancer is the second most prominent cause of deaths in women as breast cancer is one of the most common forms of invasive cancers found in women. Advancements in treatment have enhanced the survival rates drastically since 1989. Alone in the...

Best Research Paper Writers

Well-written research papers are a literary masterpiece on their own, presenting complex ideas simply and effectively, and the research paper writers are the one who prepares these papers. Research paper writers are skilled people who are masters of putting thought...

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