...MedDRA® TERM SELECTION: POINTS TO CONSIDER Release 3.13 Based on MedDRA Version 12.1 ICH-Endorsed Guide for MedDRA Users Application to Adverse Drug Reactions /Adverse Events & Medical and Social History & Indications 1 October 2009 © Copyright ICH Secretariat (c/o IFPMA) Copying is permitted, with reference to source, but material in this publication may not be used in any documentation or electronic media which is offered for sale, without the prior permission of the copyright owner. IFPMA Chemin Louis-Dunant, 15 P.O. Box 195 1211 Geneva 20 Switzerland Tel: +41 (22) 338 32 00 Fax: +41 (22) 338 32 99 2 Table of Contents 1.0 1.1 1.2 1.3 1.4 2.0 2.1 2.2 2.3 2.4 2.5 2.6 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11 3.12 3.13 3.14 3.15 3.16 3.17 3.18 3.19 3.20 3.21 3.22 3.23 3.24 3.25 3.26 4.0 4.1 4.2 INTRODUCTION ...................................................................................................................... 4 OBJECTIVE OF THIS DOCUMENT ................................................................................................. 4 PURPOSES OF USING MEDDRA ................................................................................................. 5 BACKGROUND ........................................................................................................................... 5 SCOPE OF THE POINTS TO CONSIDER ......................................................................................... 6 GENERAL PRINCIPLES...
Words: 9792 - Pages: 40
...Study on Hypolipidemic effect of some selected Rûksha Guna drugs SANGRAM MISHRA * R. R. DWIVEDI** B. RAVISHANKAR*** B. K. ASHOK**** Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar. ABSTRACT : Âyurveda as well as Philosophies accepted the Guna as the basic entity of the Srishti. Gunas can be classified under various categories like Âdhyâtmika Guna, Gurvâdi Guna, Parâdi Guna, Vishistha Guna. For the treatment purpose Gurvâdi Gunas are widely used. Among them the Snigdha Guna and Rûksha Guna are widely used in the Samhitâs. This study has been carried out to establish the Rûksha property drugs on animals as a hypolipidemic effect on induced hyperlipidemia animals. The drugs selected were having Rûksha property by Rasa panchaka. The drugs were Vachâ (Acorus calamus Linn), Kushtha (Saussurea lappa C.B. Clarke), Haridra (Curcuma longa Linn), Daruharidrâ (Berberis aristata DC), Chitraka (Plumbago zeylanica), Karanja (Pongamia pinnata Pierre). All the drugs are having Lekhana property and Srotosodhaka karma due to Rûksha property. Based on this promise the test drug (Rûksha Guna) had been studied on various experimental models such as body weight, weight of liver, heart and kidney, food intake and faecal out put, water intake, total faecal fat content etc. The selected drugs are the representative of highest magnitude of Rûksha property which are able to influence Dîpana and Pâchana property and the test drug was administered with...
Words: 4397 - Pages: 18
...Formula F3 (PEG 400 as plasticizer) showed a significant increase (P<0.05) in drug release than other plasticizer, this may due to PG increase the partition coefficient and so that increasing drug diffusion [25]. , also it was found that the higher loading of captopril, the greater amount of drug would dissolve inside the hydrated polymer matrix leading to increasing the drug diffusion rate and release [29]. Figure 2: Effect of plasticizer type on in-vitro release of captopril in phosphate buffer pH6.8 at 37 from mucoadhesive buccal patches. Figure 3:-Effect of increasing of drug amount on in-vitro release of captopril in phosphate buffer pH6.8 at 37 from mucoadhesive buccal patches. Determination of Selected Formula of Captopril Mucoadhesive Buccal Patch Formula F4 was selected for further investigation and the selectivity was made since the patch had accepted value for mechanical properties(16.06MPa, 34.14%) ,surface PH(6.44±0.21), convenient mucoadhesive strength(26.2±0.256) and suitable ex-vivo time (6.12±0.06)hrs with high drug release 94.73% for...
Words: 474 - Pages: 2
...Statement An investigation into the effects of substance abuse as a cultural habit on the health of students at Manchester High School within the age group 14- 20. Research Questions * What are the types of substances mainly abused? * How has substance abuse become a cultural habit? * What are the most devastating health effects of substance abuse? * What are the possible solutions to reduce the number of students who indulge in substance abuse? Rationale Substance abuse is a growing trend amongst teenagers including those at Manchester High and being within that age group, the researcher’s interest was generated to uncover how substance abuse as a cultural habit affects one’s health. The researcher’s aim is to educate the readers about these habits and highlight the reasons youths are involved thus identifying ways to solve the problems. The researcher also aims to fulfill the outlined requirements of the CAPE Caribbean Studies course. Delimitations The research is delimited to the effects of substances abuse from the perspectives of fourth to sixth form students at Manchester High School, located at 4 Perth Road, Mandeville Manchester. The sample size chosen was twenty (20) participants between the ages of 14-20 of both genders, which are essentially fourth to sixth form students. This group was ideal as they are the most likely group who would be aware of substance abuse. The sample size was selected as it was an easy range of students...
Words: 3430 - Pages: 14
...University of California, San Francisco, CA, USA * Corresponding author. Beijing National Laboratory for Molecular Sciences, State Key Laboratory for Structural Chemistry of Unstable and Stable Species, College of Chemistry and Molecular Engineering, and Center for Theoretical Biology, Peking University, Beijing 100871, China. Tel.: þ 86 10 6275 7486; Fax: þ 86 10 6275 1725; E-mail: lhlai@pku.edu.cn Received 23.5.08; accepted 14.9.08 Drugs against multiple targets may overcome the many limitations of single targets and achieve a more effective and safer control of the disease. Numerous high-throughput experiments have been performed in this emerging field. However, systematic identification of multiple drug targets and their best intervention requires knowledge of the underlying disease network and calls for innovative computational methods that exploit the network structure and dynamics. Here, we develop a robust computational algorithm for finding multiple target optimal intervention (MTOI) solutions in a disease network. MTOI identifies potential drug targets and suggests optimal combinations of the target intervention that best restore the network to a normal...
Words: 11216 - Pages: 45
...passage of the Anti-Drug Abuse Act of 1986, all __________ of controlled substances have themselves become controlled substances. Selected Answer: Answers: b. analogs a. agonists b. analogs c. antagonists d. designer drugs Question 2 1 out of 1 points Chemical variations of drugs are referred to as ________________. Selected Answer: Answers: c. analogs a. antagonists b. designer drugs c. analogs d. agonists Question 3 1 out of 1 points Approximately _____ adult Americans consume alcohol. Selected Answer: Answers: b. two out of every three a. three out of every four b. two out of every three c. one out of every three d. four out of every five Question 4 1 out of 1 points Most patients cannot tell the difference between heroin and morphine in equivalent doses. Selected Answer: Answers: True True False Question 5 1 out of 1 points Common short-term effects of ____________________ include drowsiness, dizziness, confusion, and mood swings. Selected Answer: Answers: d. benzodiazepine a. barbiturates b. alcohol c. heroin d. benzodiazepine Question 6 1 out of 1 points Rohypnol is known on the street as “rophies.” Selected Answer: Answers: True True False Question 7 1 out of 1 points Benzodiazepines are referred to pharmacologically as ____________________. Selected Answer: Answers: b. sedative-hypnotics a. antagonists b. sedative-hypnotics c. agonists d. polydrugs Question 8 1 out of 1 points Fentanyl is classified as a narcotic. Selected Answer: Answers:...
Words: 662 - Pages: 3
...suffering and economic resources are extraordinary. It is the most common reason for seeking medical care, and it has been estimated that approximately 80% of physician office visits involve a pain component. Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most widely used class of drugs for the management of acute and chronic pain in dentistry. NSAIDs minimize edema, but they are associated with many adverse effects, like gastric irritability, as dyspepsia and gastric bleeding which lead to a number of contraindications. Diclofenac is a powerful anti-inflammatory and analgesic drug that is well suited for local use in the oral cavity....
Words: 1279 - Pages: 6
...Effects of Drugs A Term Paper Presented to the Faculty Of the English Department Of Hope Christian High School By: Aldrin Aaron M. Agulan High 4 - Purity February 27 2013 Table of contents……… Acknowledgement……………………………..…. Introduction …..………………………………..…….1 Definition of terms …………………………….…....2 Effects of Drugs ...……….……………………..….3 Complication of addiction ....……….………………14 Conclusion …………………………………………15 Findings …………………….………………………21 Bibliography………………………………………...23 Appendix……………………………………………24 Acknowledgments I would like to thank God for his unyielding guidance on my path through this term paper. I would also like to extend my gratitude to all my family members who have supported me through the long hours. This paper would not be possible if not for the endless mentoring of my teacher Dr. Bella Divina Lastly, I would like to give thanks to my one and only almamater who have been my home since the start of my education and the wealth of knowledge she has given me. -Aldrin Introduction Many people do not understand why individuals become addicted to drugs or how drugs change the brain to foster compulsive drug abuse. They mistakenly view drug abuse and addiction as strictly a social problem and may characterize those who take drugs as morally weak. One very common belief is that drug abusers should be able to just stop taking drugs if they are only willing to change their...
Words: 4874 - Pages: 20
...adverse drug events and medication errors in intensive care units and identified that improper dose accounted for the majority of potential and actual preventable (21.1%), wrong duration of treatment (19.2%), wrong rate of administration (13.5), errors due to drug omission (9.6%), wrong administration timing (1.9%).). The studied sample of the...
Words: 775 - Pages: 4
...Question 1 0.5 out of 0.5 points A restraint of trade is an agreement between firms that has the effect of reducing competition in the marketplace. Selected Answer: Correct True Correct Answer: Correct True Question 2 0 out of 0.5 points When applying the rule of reason to determine whether an agreement violates Section 1 of the Sherman Act, a court will not consider Selected Answer: Incorrect the parties' market ability to implement the agreement. Correct Answer: Correct the effect of the agreement on international trade. Question 3 0 out of 0.5 points An act must substantially affect interstate commerce to violate antitrust law. Selected Answer: Incorrect False Correct Answer: Correct True Question 4 0.5 out of 0.5 points Gulf Air, Inc., is the major wholesale distributor of software in the state of Florida. Its closest competitor is Fluid Systems Company, another Florida firm. The two firms agree that Gulf Air will operate in south Florida and Fluid Systems will operate in north Florida. This is Selected Answer: Correct a market division. Correct Answer: Correct a market division. Question 5 0 out of 0.5 points Edgy Engine Components, Inc., a maker of vehicle parts, refuses to sell to Fidgety Fix-It, Inc., a national vehicle service firm. Edgy Engine convinces Greasy Motor Parts Company, a competitor, to do the same. This is Selected Answer: Incorrect a market division. Correct Answer: Correct a group boycott. Question 6 0.5 out...
Words: 1848 - Pages: 8
...many risk factors that can contribute to adolescent substance abuse. One of the main risk factors is peer pressure. When adolescents start at a young age there is an increase in health problems, addiction, and over all poor social outcomes. Parental influence has substantial effect on adolescents because the adolescent sees their parents and they learn by their example. Media plays a role in the use of drug and alcohol use among young people. Many school systems have implemented programs that teach adolescents about the problems of substance abuse that is funded by the government. The community health nurse helps provide education in the community. The cost for substance abuse can be astronomic. Emergency room visits, treatment programs and even court costs lead to billions of dollars annually. The key to prevention is education. Adolescent Substance Abuse In society today adolescent substance abuse is a growing problem. There are many risk factors that can lead to substance abuse. It is important to understand the reasons behind why the adolescent begins the experimentation of drugs and alcohol. Media plays a role in adolescent substance abuse. Many times advertisement and movies betray alcohol or drug use as fun and not addictive. Many times the people are happy and having a good time. This gives many young people the wrong idea about substance use. Substance abuse among young people between the ages of 12 and 20 years of age is a serious national problem. This abuse can...
Words: 1655 - Pages: 7
...has shown that there may be a relationship between the consumption of sweeteners and the rise in obesity so, this will be an opportunity to examine that facts and develop an position. Scenario/Summary: Please select one of the following sweeteners: 1. Sugar (sucrose) 2. Fructose 3. High Fructose Corn Syrup 4. Stevia 5. Equal 6. Spl 7. enda 8. Ace K 9. Or another one you can find on your own Deliverables: Answer the following questions about the sweetener you have selected: 1) Select a sweetener 2) Explore the history of the sweetener (include all of the background on this ingredient-when it was discovered, its composition by whom it was discovered, its chemical makeup, its first use, its sweetening capabilities and what foods it can be used in). 3) Discuss safety and the sweetener you have selected. 4) Examine the relationship between the sweetener you have selected and obesity. |Indicate the sweetener that you have selected. |3 points | |Discuss the history of the sweetener. Make sure to include all |6 points | |of the background on this ingredient-when it was discovered, its | | |composition by whom it was discovered, its chemical makeup, its | | |first use, its sweetening capabilities and what foods...
Words: 721 - Pages: 3
...Question 1 0.42 out of 0.42 points This is a harmful, undesirable response to a drug Selected Answer: Adverse reaction Correct Answer: Adverse reaction Question 2 0.42 out of 0.42 points When it is stated that massage may negate medication, this means that Selected Answer: Massage will produce the opposite affect wanted by the medication Correct Answer: Massage will produce the opposite affect wanted by the medication Question 3 0.42 out of 0.42 points The client has white flakes that cling to the hair shafts and don’t brush out. What condition does the client have? Selected Answer: Head lice Correct Answer: Head lice Question 4 0.42 out of 0.42 points A client has several raised red circles on his trunk. The circles are paler in the middle. He reports the circles are mildly itchy. What contagious condition is probably present? Selected Answer: Tinea corporis Correct Answer: Tinea corporis Question 5 0 out of 0.42 points Hormones and neurotransmitters are influenced by massage. Which of the following is a neurotransmitter? Selected Answer: Oxytocin Correct Answer: Serotonin Question 6 0.42 out of 0.42 points This is the most common route used to take medications. Selected Answer: Enteral Correct Answer: Enteral Question 7 0 out of 0.42 points In the stages of healing...
Words: 3019 - Pages: 13
...of a disease or condition common to persons within a localized area is known as a(n) ____.Answer | | | | | Selected Answer: | endemic | Correct Answer: | endemic | | | | | Question 2 5 out of 5 points | | | A disease or condition that affects a greater than expected (normal) number of individuals within a population, community, or region at the same time is referred to as an ____.Answer | | | | | Selected Answer: | epidemic | Correct Answer: | epidemic | | | | | Question 3 0 out of 5 points | | | HIV, the virus that causes AIDS, is currently a ____.Answer | | | | | Selected Answer: | modifiable risk factor | Correct Answer: | pandemic | | | | | Question 4 0 out of 5 points | | | The biological cause of a problem or disease is known as ____.Answer | | | | | Selected Answer: | agent | Correct Answer: | etiology | | | | | Question 5 0 out of 5 points | | | Social epidemiology studies ____.Answer | | | | | Selected Answer: | the effect of the environment on human health | Correct Answer: | the effect of community socioeconomic factors on health | | | | | Question 6 5 out of 5 points | | | Physical, biological, social, cultural, and behaviors that influence health are known as ____.Answer | | | | | Selected Answer: | determinants | Correct Answer: | determinants | | | | | Question 7 5 out of 5 points |...
Words: 1107 - Pages: 5
...Liberty University Lin Article Critic II This paper will review Lin article, Effects of Forgiveness Therapy on Anger, Mood, and Vulnerability to Substance use among Inpatient Substance-dependent Clients, and critic population of the study vs. population of interest, Operationalization aspects, Evaluation of DV measurement, and Evaluation of DV measurement. Lin, Wei-Fen. Mack, D, Enright, R, Krahn Dean, &Thomas Baskin (2004), states that the level of anger and violence observed among alcohol and substance abusers are far higher than the levels found in the general population, and coping skills have been implemented in many substance abuse programs to teach patients how to become aware of their anger and also manage their emotions effectively. Many researchers have directed their focus on Forgiveness Therapy (FT) as an alternative option to any other treatment for patients to overcome their emotional bondage, which leads them to misuse alcohol and dependency to controlled substances. The hypothesis in this study is that Forgiveness Therapy decreases the frequency and severity of anger, anxiety, and depression, and patients in residential treatment for alcohol and drug dependency have demonstrated less anger and urge towards drug use after receiving this treatment. Critic of Population of the Study This study, which took place in a residential drug rehabilitation facility, targeted the effects of Forgiveness Therapy in decreasing the frequency and severity of anger, anxiety...
Words: 1117 - Pages: 5