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Does Alcohol Cause Cancer?

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  Does alcohol cause cancer? The National Toxicology Program of the US Department of Health and Human Services recognizes alcoholic beverage intake as a suspected human carcinogen. Every year, over 20,000 adults in the United States die from alcohol-related cancers. In 2021, more than 522,000 alcohol-related cancers were identified in the United States, with over 155,000 males and 367,000 women. Breast cancer is the most common alcohol-related cancer in women. Colorectal cancer is the most common alcohol-related cancer in men . How does alcohol increase the risk of cancer? Damage to cells: When we drink alcohol, our bodies turn it into acetaldehyde, a chemical that damages cells and blocks recovery. Changes to hormones: Alcohol raises hormone levels like estrogen and insulin, promoting cell division and increasing cancer risk. Changes to cells in the mouth and throat: Alcohol increases the absorption of harmful chemicals in the mouth and throat, causing damage. How can I ...
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Patharchatta Plant and Its Benefits: Backing Claims with Evidence

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  A few days ago, my mother introduced me to a stranger at the local market, and it turned into an interesting story. Let me share with you about that: On that Sunday morning, my mother found that she was looking for a plant, Patharchatta plant , also known as the Kalanchoe pinnata in English.  But why? Her husband is suffering from gall bladder stones, and she is hoping to find this plant. Someone told her about this plant and its benefits. However, she couldn’t find it in half of Bangalore. When she showed the picture of the plant, luckily, my mother recognized the plant, growing in our backyard. My mother immediately stared at me, so I could help her, as I am a pharmacist. I recollected the name of the plant from our pharmacognosy lessons. But I was not sure about its use for dissolving gallbladder stones. So, how can I help her? What should I do now? I am a medical writer and a responsible pharmacist; hence, I requested her to give me some time. So that...
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DIABETES IN INDIA - STATISTICS

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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...
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REGULATORY DOCUMENTS IN PHARMACEUTICAL INDUSTRY

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  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...
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WHAT IS PROTOCOL IN CLINICAL TRIALS?

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  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...
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INVESTIGATOR'S BROCHURE IN CLINICAL TRIALS

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INVESTIGATOR'S BROCHURE IN CLINICAL TRIALS The Investigator's Brochure (IB) serves as a resource for clinical trial investigators. It highlights the key components of a product's development to date. It reviews nonclinical and clinical findings. It suggests ways to study the new product's benefits and dangers. Regulatory Guidance on Structure and Content Section 7 of ICH E6 lists the highest-level sections as follows: Summary Introduction Physical, chemical, and pharmaceutical properties and formulation Non-clinical studies Effects in humans Summary of data and investigator instructions. When researchers conduct the first human clinical trial, they require an IB. According to ICH E6, a team should review an IB at least once a year and revise it when necessary. However, the team may increase the frequency of revisions based on the development stage and new relevant information. The Six Main Sections of an IB Summary This part summarizes the next sections. It profil...
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