The Medical Writer

UNDERSTANDING DIABETES: GLOBAL IMPACT, TRENDS, AND VIEWS FROM INDIA What is diabetes? Diabetes is a lifelong condition in which blood sugar levels are above normal due to the body's inability to produce enough insulin or use it correctly. Development of Diabetes Types of diabetes Type 1 diabetes starts when the immune system mistakenly targets the pancreatic cells that produce insulin. This causes the body to produce little or no insulin. Type 1 Diabetes People with type 1 diabetes need daily insulin injections to keep their blood glucose levels within normal ranges. They would not live without insulin. Type 2 diabetes arises from the body's cells not responding correctly to insulin, known as insulin resistance. This reduces insulin's use, triggering the body to create more insulin over time. Type 2 Diabetes It is the most common type of diabetes, responsible for more than ninety percent of the cases worldwide. Prediabetes refers to higher-than-normal blood sugar levels...

  REGULATORY DOCUMENTS IN PHARMACEUTICAL INDUSTRY Investigational New Drug Application (IND) It is an application from a clinical research sponsor to the Food and Drug Administration (FDA) for authorization for administering an investigational drug to humans. INDs are classified into three types: An investigator IND is submitted by a physician who begins and investigates the clinical trial drug and manages its administration or dispensing. Emergency Use IND allows the FDA to authorize the use of an investigational drug in an emergency situation that does not allow for the submission of an IND in compliance with 21 CFR. Treatment INDs are submitted for investigational drugs that show promise in clinical testing for serious life-threatening illnesses. IND applications must include information in three broad areas: Animal Pharmacology and Toxicology Studies Manufacturing Information Clinical Protocols and Investigator Information Three Important Componates of IND Once the IND is sub...

  PROTOCOL IN CLINICAL TRIALS A clinical research protocol is a detailed plan. It guides researchers in conducting a clinical trial. It acts as an action plan, outlining every essential aspect of the study and how it will be executed. Importance of Protocol   To protect the rights and well-being of participants. To ensure scientific integrity and reliability. To promote transparency and accountability. To ease collaboration and reproducibility. To guide resource allocation and management. A clinical research protocol is vital for ethical, reliable, high-quality research. Protocol as a Roadmap in Clinical Research It defines the research question, objectives, method, and population. It also details the treatments, assessments, and statistical analysis plan. This ensures careful planning of all study aspects. A protocol outlines a sequence of study activities. It covers screening, recruiting participants, collecting data, and analyzing it. Milestones and Timefram...