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Guidance for Industry Acne Vulgaris:  Developing Drugs for Treatment DRAFT GUIDANCE
Guidance for Industry Acne Vulgaris: Developing Drugs for Treatment DRAFT GUIDANCE

... This document is intended to provide guidance to the pharmaceutical industry on the development of drug products for the treatment of acne vulgaris other than nodulocystic acne. The information presented will help applicants plan clinical studies, design clinical protocols, implement and appropriate ...
Prescribing - North Essex Partnership University NHS Foundation
Prescribing - North Essex Partnership University NHS Foundation

...  Be satisfied there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy  Take responsibility for prescribing the medicine and for overseeing the patient’s care, monitoring, and any follow up treatment, or ensure that arrangements are made for another s ...
UKMI Guidance: Temazepam Shortage
UKMI Guidance: Temazepam Shortage

... effective strategy to encourage patients to decrease or stop their medication and 16-30% did so as a result. In these studies, there was also an improvement in general health status of those who stopped hypnotic treatment. It also found that if letters requesting patients to stop were issued, the ‘n ...
Supplemental Figure Legends
Supplemental Figure Legends

... Carboplatin 50mg/kg/week (IP), ABT888 25mg/kg/day (OG) or combination Carboplatin+ABT888 (doses as in single agent therapy). (A) Median survival of MDA-MB468 basal-like intracranial TNBC model. Treatment started on day 14 after intracranial implantation. (B) Median survival of MDA-MB231BR intracrani ...
QuickTox Drug Screen Dipcard Quick Reference Guide
QuickTox Drug Screen Dipcard Quick Reference Guide

... OPI: Heroin, morphine and codeine are opiates that are derived from the resin of the opium poppy. Heroin is quickly metabolized to morphine. Thus, morphine and morphine glucuronide may both be found in the urine of a person who has taken only heroin. The body also converts codeine to morphine. Thus, ...
Revised: January 2016 AN. 01318/2015 SUMMARY OF PRODUCT
Revised: January 2016 AN. 01318/2015 SUMMARY OF PRODUCT

... Plasma theophylline levels may increase in patients under treatment with macrolide and fluoroquinolone antibiotics, such as erythromycin and enrofloxacin, and decrease in patients receiving phenobarbitone or phenytoin. Theophylline may reduce the convulsive threshold in patients receiving ketamine. ...
The tragic history of AIDS in the hemophilia population
The tragic history of AIDS in the hemophilia population

... recruitment and screening practices. The hemophilia groups expressed concerns that the data showing immune suppression in hemophilic patients could have reflected the effects of prolonged use of blood products and did not necessarily mean they had the new syndrome. They also feared the stigma of havi ...
Drugs for Parkison`s disease and Alzheimer`s disease
Drugs for Parkison`s disease and Alzheimer`s disease

... patients of discontinuation of L-dopa due to adverse effects, Parkinsonian syndrome induced by phenothiazides ...
A Word About the 2013 PAD Guidelines
A Word About the 2013 PAD Guidelines

... product(s)/device(s) and/or provider(s) of commercial services included in this educational activity. The intent of this disclosure is not to prevent a person with a relevant financial or other relationship from participating in the activity, but rather to provide participants with information on wh ...
Geographic Distribution And Adaptive Significance
Geographic Distribution And Adaptive Significance

... introgressions may have affected modern human phenotypes (e.g., HuertaSánchez et al. 2014). These adaptive genetic variants are starting to give us a glimpse of the complex ecological, cultural and social pressures that shape the contemporary human genetic diversity. Overall, new sequencing technol ...
1 IN THE UNITED STATES DISTRICT COURT FOR
1 IN THE UNITED STATES DISTRICT COURT FOR

... pediatric patients. See id. at ¶ 16. FDA ultimately approved Otsuka’s sNDA for Abilify® for treatment of Tourette’s Disorder in the pediatric population. See AR 468-69. As a result of FDA’s decision, Otsuka obtained approval for a pediatric Tourette’s Disorder indication for Abilify® that is protect ...
Comparative Steady State Cross-Over Bioequivalence Study of
Comparative Steady State Cross-Over Bioequivalence Study of

... tablet formulations were compared in a randomized, open-label, balance, two-treatment, two-period, two-sequence, cross-over steady state bioequivalence study. The subjects were administered treatment in a crossover manner under fed conditions according to the randomization schedule. Steady state dos ...
Introduction to Generic Drug Product Development
Introduction to Generic Drug Product Development

... • Where these above methods are not applicable (e.g., for drug products that are not intended to be absorbed into the bloodstream), other in vivo or in vitro test methods to demonstrate bioequivalence may be appropriate. • Bioequivalence may sometimes be demonstrated using an in vitro bioequivalence ...
Ranibizumab or bevacizumab in AMD?
Ranibizumab or bevacizumab in AMD?

tG TG
tG TG

... Section of chromosome (DNA) that codes for a specific trait. Reproductive cell. A diagram of the genetic history of an individual: can show how a trait is inherited over several generations of a family. (a genetic family tree) Any one of two or more alternative forms of a gene that may occur alterna ...
Characterization of Deletions in the LDL Receptor Gene in Patients
Characterization of Deletions in the LDL Receptor Gene in Patients

Naloxone as a Mu-Receptor Antagonist
Naloxone as a Mu-Receptor Antagonist

... naloxone-3-glucuronide as the major metabolite. Further research to improve half-life should include areas such as modification of the nitrogen substituent to prevent N-demethylation, circled in Figure 5: Naloxone structure with blue in Figure 5, and the 6-ketone to slow possible areas of modificati ...
PREPARATION AND EVALUATION OF FLUOXEITINE HYDROCHLORIDE ORAL DISPERSIBLE TABLETS Research Article
PREPARATION AND EVALUATION OF FLUOXEITINE HYDROCHLORIDE ORAL DISPERSIBLE TABLETS Research Article

... The oral route of administration still continue to be the most preferred route due to its manifold advantages including ease of ingestion, pain avoidance, versatility and most importantly patient compliance. Recent advances in novel drug delivery systems aim to enhance safety and efficacy of drug mo ...
Clinical Practice Guidelines APPENDIX 1 MEDICATION FORMULARY
Clinical Practice Guidelines APPENDIX 1 MEDICATION FORMULARY

... The context for administration of the medications listed here is outlined in the CPGs. Every effort has been made to ensure accuracy of the medication doses herein. The dose specified on the relevant CPG shall be the definitive dose in relation to practitioner administration of medications. The pr ...
eeg
eeg

... EEG has been devalued by the industry largely due to: – Disbelief in the value of EEG as a biomarker due to past failures with a wide variety of causes, including ‘over-promising’ what it can deliver – The advance of imaging techniques, which were thought to supersede EEG as a "window into the brain ...
09107sgp06
09107sgp06

... Moreover, safer means of taking the drug, such as smoking or nasal, oral and rectal insertion are encouraged, due to injection having higher risks of overdose, infections and blood-borne viruses. Where the strength of the drug is unknown, users are encouraged to try a small amount first to gauge the ...
Presentation (MS PowerPoint 4MB)
Presentation (MS PowerPoint 4MB)

... drugs or alcohol6 – Polydrug use is predominant pattern of use in Australia6 – Respondents reported driving within 3 hours of taking: • Analgesics (44.8%) • Prescription stimulants (43%) • Benzodiazepines (30.3%) ...
OXCARBAZEPINE
OXCARBAZEPINE

... • Oxcarbazepine is itself a second-line augmenting agent for numerous other anticonvulsants, lithium, and atypical antipsychotics in treating bipolar disorder, although its use in bipolar disorder is not yet well studied • Oxcarbazepine may be a second- or thirdline augmenting agent for antipsychoti ...
Alcohol Abuse: New Approaches to Treatment
Alcohol Abuse: New Approaches to Treatment

... Next treatment study will examine effects of olanzapine and a more intense psychosocial intervention on drinking with 1 year follow-up Ultimately, olanzapine may point to better medications This work is a methodological illustration of how to uncover genetic factors that may influence etiology and t ...
Quantitative Inheritance - NAU jan.ucc.nau.edu web server
Quantitative Inheritance - NAU jan.ucc.nau.edu web server

... Analysis of selection on corolla height • East was able, with only 3 generations of artificial selection, to recover phenotypes that resembled the parents — the parental alleles were still there — short and tall corollas had not been lost by blending inheritance • In modern terminology, we would sa ...
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Pharmacogenomics

Pharmacogenomics (a portmanteau of pharmacology and genomics) is the study of the role of genetics in drug response. It deals with the influence of acquired and inherited genetic variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms with drug absorption, distribution, metabolism and elimination, as well as drug receptor target effects. The term pharmacogenomics is often used interchangeably with pharmacogenetics. Although both terms relate to drug response based on genetic influences, pharmacogenetics focuses on single drug-gene interactions, while pharmacogenomics encompasses a more genome-wide association approach, incorporating genomics and epigenetics while dealing with the effects of multiple genes on drug response.Pharmacogenomics aims to develop rational means to optimize drug therapy, with respect to the patients' genotype, to ensure maximum efficacy with minimal adverse effects. Through the utilization of pharmacogenomics, it is hoped that drug treatments can deviate from what is dubbed as the “one-dose-fits-all” approach. It attempts to eliminate the trial-and-error method of prescribing, allowing physicians to take into consideration their patient’s genes, the functionality of these genes, and how this may affect the efficacy of the patient’s current and/or future treatments (and where applicable, provide an explanation for the failure of past treatments). Such approaches promise the advent of ""personalized medicine""; in which drugs and drug combinations are optimized for each individual's unique genetic makeup. Whether used to explain a patient’s response or lack thereof to a treatment, or act as a predictive tool, it hopes to achieve better treatment outcomes, greater efficacy, minimization of the occurrence of drug toxicities and adverse drug reactions (ADRs). For patients who have lack of therapeutic response to a treatment, alternative therapies can be prescribed that would best suit their requirements. In order to provide pharmacogenomic-based recommendations for a given drug, two possible types of input can be used: genotyping or exome or whole genome sequencing. Sequencing provides many more data points, including detection of mutations that prematurely terminate the synthesized protein (early stop codon).
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