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Addex Pharmaceuticals
Addex Pharmaceuticals

... Dipraglurant-ER (ADX48621) mGluR5 NAM – non-Parkinsonian dystonias GABA-BR PAM – pain, overactive bladder mGluR2 NAM – Alzheimer’s, depression mGluR4 PAM – Parkinson’s disease, anxiety FSHR/LHR NAM – sex hormone dependent tumors & reproductive system disorders mGluR7 NAM – Anxiety / Depression, PTSD ...
Principles of Analgesic Use in the Treatment of Acute Pain
Principles of Analgesic Use in the Treatment of Acute Pain

... clinical data or clinical experience, altering the size of the patch will affect the pharmacology and is not consistent with clinical studies. However, the product label for the Lidoderm® (lidocaine) patch, which is manufactured by the same factory as the diclofenac patch and is similar in design, d ...
Central nervous system (including peripheral analgesics)
Central nervous system (including peripheral analgesics)

... than the recommended dose, or taking the drug for a longer period of time than recommended increases the risk of bleeding.5,6 The appearance of blood or occult blood in any vomit or stool may indicate stomach bleeding, and a physician should be consulted immediately. If an individual experiences sto ...
Uveitis and Topamax – Dr. Amir Hadayer
Uveitis and Topamax – Dr. Amir Hadayer

... Mitra A, Ramakrishnan R, Kader MA. Anterior segment optical coherence tomography documentation of a case of topiramate induced acute angle closure. Indian Journal of Ophthalmology. 2014;62(5):619-622. Acharya N, Nithyanandam S, Kamat S. [Letter to the Editor] Topiramate-associated bilateral anterior ...
annexure-ii
annexure-ii

... under coagulation condition at 4˚C in the presence of gelatin. Cross-linking TPP solution pH and other preparation factors had an effect on the drug release performance of beads. It seems that TPP/chitosan bead prepared by the novel method is a promising formulation for drug delivery11. 6. Carmen Re ...
presentation here.
presentation here.

... ■ History of ulcer adverse effects ■ Consider a gastro-protective agent when appropriate ■ American Geriatric Society recommends low dose opioids in geriatric population ■ Liver impairment ■ May compromise kidney function ...
Hypersensitivity reactions to anticancer agents: Data mining of the
Hypersensitivity reactions to anticancer agents: Data mining of the

... array of symptoms from mild flushing and itching to lethal anaphylaxis. The pathogenic mechanisms by which the reactions occur are still unclear, although they seem to vary widely among agents. The exact prevalence of these reactions is difficult to evaluate, and such a problems is hindering the est ...
Systemic Treatment Clinical Trials Request Intake Form
Systemic Treatment Clinical Trials Request Intake Form

... delivery, and related clinical care for patients. The request will be reviewed jointly by the Systemic Treatment Quality Based Program (ST-QBP) and the New Drug Funding Program (NDFP), where appropriate. Prior to completing the form, please ensure that the request is for a new clinical trial, and:  ...
Chapter 1
Chapter 1

... • Filling and packaging bulk products in individual containers for customer use • Metrology ensures instruments are operating properly • Facilities technicians maintain critical day to day functions such as housekeeping and repairs ...
Revised: May 2015 AN: 00567/2014 SUMMARY OF PRODUCT
Revised: May 2015 AN: 00567/2014 SUMMARY OF PRODUCT

Attachment 1. Product Information - Therapeutic Goods Administration
Attachment 1. Product Information - Therapeutic Goods Administration

WHAT IS NEW IN OSTEOARTHRITIS? SYSADOA CLINICAL REVIEW
WHAT IS NEW IN OSTEOARTHRITIS? SYSADOA CLINICAL REVIEW

... for months even after treatment suppression). Moreover, these drugs have a high safety profile and the ratio cost/effectiveness is low. The main SYSADOAs are chondroitin sulfate (CS), glucosamine sulfate (GLU) and hyaluronic acid (HA). They are specially indicated in elderly patients, often ...
INTRODUCTION TO SCIENTIFIC RESEARCH
INTRODUCTION TO SCIENTIFIC RESEARCH

... • Clearance (CL): the measurement of blood cleared of the drug by elimination per unit time (as in units of mL/sec). It and the volume of distribution (Vd) create the ...
DSQ Fall 2013 - American College of Rheumatology
DSQ Fall 2013 - American College of Rheumatology

... In contrast to methotrexate there is relatively little information on the risks of continuation of other DMARDs and the biological agents in the perioperative period(8,19). There are no randomized studies addressing perioperative complications in RA patients treated with other commonly used antirheu ...
Introduction - KSU Faculty Member websites
Introduction - KSU Faculty Member websites

... effects varies widely from person to person but can easily be determined by each individual. Moreover, these side effects can be eliminated by reducing the dose. Most people who take vitamin C supplements know how much they can tolerate; for those who do not, a simple warning on bottles of vitamin ...
Pediatric inflammatory bowel disease clinical trials: is there a
Pediatric inflammatory bowel disease clinical trials: is there a

... • Genetics and response to therapy are similar in older children and adults (Jeffrey Hyams, GREAT 2) • IBD in a 17 year old is probably the same as IBD in an 18 year old (i.e. legal age has no bearing on biology) • However, IBD in a 5 year old (or in an 80 year old) may well be different from IBD in ...
FORM: Application for Human Research
FORM: Application for Human Research

... Evidence of qualifications of the key personnel related to their role in this research (biosketch, resume, CV, other description) Protocol Template (If this is the activation of a previously approved protocol at a new site or sites that will be overseen by a principal investigator who will take sepa ...
Reflection paper on the use of cocrystals of active - EMA
Reflection paper on the use of cocrystals of active - EMA

Waiver of In Vivo Bioavailability and Bioequivalence
Waiver of In Vivo Bioavailability and Bioequivalence

Enrocare 10% Injection
Enrocare 10% Injection

rajiv gandhi university of health sciences, karnataka
rajiv gandhi university of health sciences, karnataka

... Transdermal Drug delivery systems (TDDS) by virtue of its rate limiting property of stratum corneum offer many benefits over conventional drug therapy. It can decrease fluctuation in plasma drug concentrations and increase bioavailability by bypassing the hepatic first pass metabolism. Lower inciden ...
hepatic impairment studies in early development services
hepatic impairment studies in early development services

- Premier University of Technology
- Premier University of Technology

... Patents Definition, Need for patenting, Types of Patents, Conditions to be satisfied by an invention to be patentable, Introduction to patent search. The essential elements of patent; Guidelines for preparation of laboratory note book, Non-obviousness in Patent, Drafting of Patent claims, Important ...
Drug Utilization Review Board - The Oklahoma Health Care Authority
Drug Utilization Review Board - The Oklahoma Health Care Authority

... For Public Comment; Brad Clay: Hello, good evening. My name is Brad Clay. I’m an outcomes and economics medical liaison in Amgen scientific affairs. I’m here to discuss briefly Enbrel or etanercept. The first think I want to do is make this committee and its’advisors aware that in the last ten days ...
Update Drug Safety Latest advice for all medicines users
Update Drug Safety Latest advice for all medicines users

... overlapping 95% CI suggest that any difference between the two groups is not significant. The outcome studies do not fully reflect the pharmacokinetics of PPIs, so there may be more than one explanation for the effect of this class of medicines on clopidogrel. More evidence from clinical-outcome stu ...
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Biosimilar

A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product which is a copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original ""innovator"" products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Follow-on manufacturers do not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance. They do have access to the commercialized innovator product.Drug related authorities such as European Medicines Agency (EMA), Food and Drug Administration (FDA), and Health Canada hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy. According to them, analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; animal studies (including the assessment of toxicity); and a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product.In case of a monoclonal antibody-containing medicinal product, such as Remsima, extensive physicochemical and biological characterization for it and its reference product Remicade was conducted in order to demonstrate their highly similar properties. Consequently, EMA have granted a marketing authorisation for only a few numbers of biosimilars since 2006 including a monoclonal antibody which is recently approved. Meanwhile, on March 6, 2015, the FDA approved the United States's first biosimilar product, the biosimilar filgrastim Zarxio.
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