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Quality assurance unit 2.pdf
In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the
Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of
pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical
Quality Assurance is one of them.
Plethysmometer
The digital plethysmometer is a tool that can accurately measure paw swelling in rats and mice to evaluate inflammatory response and screen for potential anti-inflammatory drugs. It uses a displacement method to measure paw volume changes with high accuracy and resolution of 0.01 ml. The device has a stable graphical LCD display, automatic calibration, and can store data for up to 100,000 experiments.
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The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
Quality assurance unit 3.pdf
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise boosts blood flow and levels of serotonin and endorphins which elevate mood and may help prevent mental illness.
Quality assurance unit 5.pdf
In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the
Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of
pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical
Quality Assurance is one of them.
Bioassay of Digitalis
This document describes the bioassay method for determining the potency of digitalis extracts using guinea pigs and pigeons. The potency of a test sample is compared to a standard digitalis preparation by determining the lethal dose needed to arrest the heart. For guinea pigs, the extract is administered via cannulated jugular vein until heart arrest, and the lethal dose is calculated. For pigeons, the lethal dose per kg that causes heart arrest or emesis is determined and used to calculate the potency relative to the standard. Proper preparation of extracts, use of minimum 6 animals, and determination of average lethal doses are described.
Anxiety Pharmacology
types of fear, Anxiety pharmacology, advance pharmacology, drugs for anxiety, treatment of anxiety, management of anxiety.
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Chronopharmacology is the study of variations in drug effects over biological times and circadian rhythms. It considers how drugs interact with living systems depending on the time of day they are administered. Biological rhythms like circadian (24-hour), ultradian (<20 hours), and infradian (>28 hours) rhythms influence physiological functions and drug pharmacokinetics and pharmacodynamics. Chronotherapy aims to increase drug efficacy and safety by timing drug administration according to biological rhythms. It has applications in treating cancers, asthma, hypertension, strokes, and other conditions. Recent advances include circadian-aligned drug delivery systems and future approaches may integrate chronopharmacology with systems biology and nanomedicine.
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Quality assurance unit 2.pdf
In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the
Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of
pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical
Quality Assurance is one of them.
Plethysmometer
The digital plethysmometer is a tool that can accurately measure paw swelling in rats and mice to evaluate inflammatory response and screen for potential anti-inflammatory drugs. It uses a displacement method to measure paw volume changes with high accuracy and resolution of 0.01 ml. The device has a stable graphical LCD display, automatic calibration, and can store data for up to 100,000 experiments.
4.6 acth and corticosteroids
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
Quality assurance unit 3.pdf
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise boosts blood flow and levels of serotonin and endorphins which elevate mood and may help prevent mental illness.
Quality assurance unit 5.pdf
In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the
Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of
pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical
Quality Assurance is one of them.
Bioassay of Digitalis
This document describes the bioassay method for determining the potency of digitalis extracts using guinea pigs and pigeons. The potency of a test sample is compared to a standard digitalis preparation by determining the lethal dose needed to arrest the heart. For guinea pigs, the extract is administered via cannulated jugular vein until heart arrest, and the lethal dose is calculated. For pigeons, the lethal dose per kg that causes heart arrest or emesis is determined and used to calculate the potency relative to the standard. Proper preparation of extracts, use of minimum 6 animals, and determination of average lethal doses are described.
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types of fear, Anxiety pharmacology, advance pharmacology, drugs for anxiety, treatment of anxiety, management of anxiety.
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Chronopharmacology is the study of variations in drug effects over biological times and circadian rhythms. It considers how drugs interact with living systems depending on the time of day they are administered. Biological rhythms like circadian (24-hour), ultradian (<20 hours), and infradian (>28 hours) rhythms influence physiological functions and drug pharmacokinetics and pharmacodynamics. Chronotherapy aims to increase drug efficacy and safety by timing drug administration according to biological rhythms. It has applications in treating cancers, asthma, hypertension, strokes, and other conditions. Recent advances include circadian-aligned drug delivery systems and future approaches may integrate chronopharmacology with systems biology and nanomedicine.
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The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise stimulates the production of endorphins in the brain which elevate mood and reduce stress levels.
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The document discusses the history and development of chocolate over centuries. It details how cocoa beans were first used as currency by the Maya and Aztecs before being introduced to Europe in the 16th century. Chocolate became popularized as a drink in Europe in the 17th century and the first chocolate factory was opened in England in the late 1600s.
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In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the
Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of
pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical
Quality Assurance is one of them.
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Herb drug and herb food interaction ppt by nitesh kumar
HERB DRUG AND HERB FOOD INTERACTION IS AN IMPORTANT CHAPTER IN HERBLA DRUG TECHNOLOGY IN THE SYLLABUS OF B.PHARMACY 6TH SEM. IT GIVES A BETTER UNDERTANDING OF HERB FOOD INTERACTION AND RELATED DRUGS.
Document Maintenance in Pharmaceutical Industry
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❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
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Evaluation of Parentrals
The document discusses the evaluation of parenteral products. It provides an overview of parenterals, including their routes of administration and quality control tests. Key points covered include:
1) Parenterals are sterile solutions or suspensions administered outside the intestines, such as injections.
2) Quality control tests evaluate sterility, pyrogens, particulates, weight variation, and closure integrity.
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This document outlines a study to measure the locomotor activity of mice using an actophotometer. The actophotometer uses photocells to record the number of times a mouse breaks the beam of light, providing a measure of its motor activity. The study will test the effects of diazepam and caffeine on motor activity, with diazepam expected to reduce activity as a CNS depressant and caffeine expected to increase activity as a CNS stimulant. Mice will be injected with each drug and their motor activity measured and compared to baseline. The results will show the percentage change in motor activity caused by each drug.
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This study evaluated the effect of insulin on rabbits at different time intervals. Rabbits were given 20 units of insulin prepared with saline, HCl, phenol, and glycerin. Blood glucose levels were measured before insulin injection and over the next 5 hours. The results showed that insulin decreased blood glucose levels over time, with the maximum decline occurring at 2 hours, demonstrating insulin's hypoglycemic effect. This confirms that insulin regulates blood glucose levels by absorbing glucose from the blood into cells.
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The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
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Herbal excipients which are easily available, lower cost and are noncarcinogenic, which can be used to replace synthetic excipients which are carcinogenic.
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Novel Drug Delivery System is like subject enlist in B.pharm 7th sem. so from my side I cover all the Topics and units which listed in NDDS.
Quality assurance unit 4.pdf
In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the
Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of
pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical
Quality Assurance is one of them.
Qualification of UV VISIBLE SPECTROPHOTOMETER
This document discusses the qualification of UV-visible spectrophotometry. It begins by defining qualification as an act or process to ensure something complies with conditions, standards, or requirements. There are four types of qualification: design, installation, operational, and performance. UV-visible spectroscopy is concerned with the ultraviolet and visible regions ranging from 200-780 nm. The document outlines parameters for acceptance procedures and performance qualification of a UV-visible spectrophotometer, including wavelength accuracy, stray light, resolution power, noise, baseline flatness, stability, photometric accuracy, and linearity.
Dissolution chapter
Introduction to Dissolution equipment's, Calibration of dissolution apparatus, Dissolution procedure development and validation, Dissolution method development for generic drug products.
Quality control tests for parenterals ppt
This document discusses quality control tests that are performed on parenteral products. It describes 7 key tests: uniformity of content, volume of liquid, pyrogen, sterility, clarity of solution, uniformity of weight, and bacterial endotoxin. These tests ensure parenteral products meet standards for dosage uniformity, volume accuracy, freedom from fever-causing substances, freedom from microbes, visibility of solutions, weight consistency, and limits on bacterial contaminants. The tests are important for ensuring parenteral products are safe and effective for patients.
Adverse drug reactions
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Vaccine-Pharmacovigilance
This document provides an overview of vaccine pharmacovigilance (PV). It defines vaccine PV and outlines key differences from standard pharmacovigilance. The goals of vaccine PV are to detect and respond to adverse events following immunization (AEFI) to minimize health impacts. Special considerations for vaccine PV include the fact that vaccines are given to healthy populations, including mandatory childhood vaccines. Effective communication is important given perceptions around vaccine safety can impact immunization rates. Vaccine PV plays an essential role in vaccine regulation and the Global Vaccine Safety Blueprint aims to establish capacity for vaccine safety monitoring worldwide.
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This document discusses biosimilars and their manufacturing and regulation. It defines biosimilars as biological products that are similar but not identical to already approved biologics. Their manufacturing involves analyzing the reference product and replicating its structure through living cell cultures. Biosimilars undergo clinical trials to demonstrate similarity in safety and efficacy. Regulatory approval requires demonstrating comparability to the reference product. Issues include potential differences in efficacy and immunogenicity compared to the reference product.
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HERB DRUG AND HERB FOOD INTERACTION IS AN IMPORTANT CHAPTER IN HERBLA DRUG TECHNOLOGY IN THE SYLLABUS OF B.PHARMACY 6TH SEM. IT GIVES A BETTER UNDERTANDING OF HERB FOOD INTERACTION AND RELATED DRUGS.
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❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
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(PCI Syllabus New)
TOXICOKINETICS EVALUATION IN PRECLINICAL STUDIES.pptx
This document discusses toxicokinetics evaluation and saturation kinetics in preclinical studies. It defines toxicokinetics and its primary and secondary objectives in preclinical testing according to ICH guidelines. It outlines the general principles and types of toxicokinetic studies conducted at different stages of preclinical development, including safety assessment studies, single/rising dose studies, repeated dose toxicity studies, genotoxicity studies, reproduction toxicity studies, and carcinogenicity studies. It also discusses saturation kinetics, how non-linear pharmacokinetics can occur due to saturation of absorption, distribution, metabolism or excretion processes, and how non-linearity is detected.
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Good prescription habits in details, 25 common mistakes in prescriptions made by Doctors in India, Safe clinic practices, How to decrease chances of prescription errors.
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The document discusses the evaluation of parenteral products. It provides an overview of parenterals, including their routes of administration and quality control tests. Key points covered include:
1) Parenterals are sterile solutions or suspensions administered outside the intestines, such as injections.
2) Quality control tests evaluate sterility, pyrogens, particulates, weight variation, and closure integrity.
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Date: May 29, 2024
Tags: Information Security, ISO/IEC 27001, ISO/IEC 42001, Artificial Intelligence, GDPR
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