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150917 AV Basel Presentation
150917 AV Basel Presentation

Over The Counter drugs during Pregnancy
Over The Counter drugs during Pregnancy

... known to adversely affect the fetus. The safety profile of some medications may change according to the gestational age of the fetus. Because an estimated 10 percent or more of birth defects result from maternal drug exposure, the U.S. Food and Drug Administration has assigned a risk category to eac ...
Psychology 472 Pharmacology of Psychoactive Drugs
Psychology 472 Pharmacology of Psychoactive Drugs

... • Cannot penetrate the Blood-Brain Barrier • Cannot penetrate other cell membranes ...
Ephedra Fact Sheet: Metabolife and Metab-O-lite
Ephedra Fact Sheet: Metabolife and Metab-O-lite

... Ma Huang, ephedrine, or ephedra is a central nervous system stimulant that suppresses the appetite. People who take supplements containing ephedra report feeling "jittery," or like they have taken "speed," a street term for amphetamine. Caffeine is also a stimulant, acting to "boost energy" and exte ...
Canaccord Genuity Annual Growth Conference
Canaccord Genuity Annual Growth Conference

Maximizing the Use of Single
Maximizing the Use of Single

Therapeutic drug monitoring
Therapeutic drug monitoring

... metabolism with some active metabolites. Volume of distribution: 0.8 to 1.9L/kg. Factors affecting plasma concentration: Increased in hepatic disease and by concurrent use with erythromycin, cimetidine, diltiazem, verapamil and ...
summary of product characteristics
summary of product characteristics



... What I’m going to talk about this morning is the state, the current state of the U.S. drug regulatory system. ...
Lutinus vaginal tablet ENG SmPC
Lutinus vaginal tablet ENG SmPC

... Because progesterone may cause some degree of fluid retention, conditions that might be influenced by this factor (e.g. epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation. A decrease in insulin sensitivity and thereby in glucose tolerance has been observed in a sma ...
RTF - OTC Markets
RTF - OTC Markets

... adequate safety, efficacy or tolerability in one or more such studies, including vepoloxamer in the EPIC study; the risk that, even if EPIC results are positive, the FDA or other regulatory agencies may determine they are not sufficient to support a new drug application; uncertainties related to fut ...
RTF - OTC Markets
RTF - OTC Markets

6Control Drug Delivery System
6Control Drug Delivery System

First Oral Dose in Humans
First Oral Dose in Humans

Medical Devices and Pediatrics
Medical Devices and Pediatrics

... called for the IOM to assess the system under the FDA for the post-market surveillance of medical devices in pediatric populations  The IOM report was published in 2005 and made many recommendations including:  The FDA should develop additional guidance on the identification and evaluation of pedi ...
RISK MANAGEMENT IN EARLY CLINICAL TRIALS – A CRO
RISK MANAGEMENT IN EARLY CLINICAL TRIALS – A CRO

... © 2016 PAREXEL INTERNATIONAL CORP. / 10 ...
Introduction to the WHO Drug Dictionary
Introduction to the WHO Drug Dictionary

... processed and put into the structure of the WHO Drug Dictionaries and it has been coded with the dictionary's codes and IDs. The data from IMS Health also keeps the dictionary up-to-date with new drug launches and modifications to the existing drugs. The fast and frequent update of the dictionary en ...
Identification of novel therapeutics for complex diseases from
Identification of novel therapeutics for complex diseases from

RELAGESIC Liquid - International Ethical Labs
RELAGESIC Liquid - International Ethical Labs

... of alcohol and other central nervous system depressants (hypnotics, sedatives, tranquilizers and anti-anxiety drugs) while taking this product may have an additive effect on drowsiness. • If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next do ...
E 11 Clinical Investigation of Medicinal Products in the
E 11 Clinical Investigation of Medicinal Products in the

... the pediatric population, following assessment of initial safety data and reasonable evidence of potential benefit. Pediatric study results should be part of the marketing application database. In circumstances where this has not been possible, lack of data should be justified in detail. 2.3.3 Medic ...
Anti-Idiotype Antibodies
Anti-Idiotype Antibodies

... To understand the underlying dynamic relationship between mAb and L to facilitate dose and dosing schedule selection L = target ligand in circulation mAb = monoclonal antibody therapeutic ...
Developmental Pharmacokinetics
Developmental Pharmacokinetics

... and Holford 2008). Although it is often convenient to classify pediatric patients on the basis of postnatal age for the study and provision of drug therapy (e.g., newborn infants aged 1 month or less, infants between 1 and 24 months of age, children between 2 and 12 years of age, and adolescents bet ...
FORMULATION AND EVALUATION OF MODIFIED PULSINCAP DRUG DELIVERY SYSTEM OF
FORMULATION AND EVALUATION OF MODIFIED PULSINCAP DRUG DELIVERY SYSTEM OF

... The filled capsules pass the weight variation test as their weights are within the specified limits and The thickness of the CAP coating was measured by using screw gauge the values ranged from 0.056-0.071 ...
biliary excretion
biliary excretion

... Some drugs which are excreted as glucuronides/ as glutathione conjugates are hydrolyzed by intestinal/ bacterial enzymes to the parent drugs which are reabsorbed. The reabsorbed drugs are again carried to the liver for resecretion via bile into the intestine. This phenomenon of drug cycling between ...
The Safety of COX
The Safety of COX

... NSAIDs. Therefore, at this time, changes to the prescribing information for all of these drugs are warranted, until the risk profile of the individual agents can be better assessed. Non-prescription Non-Selective NSAIDs- The labeling for low dose, non-prescription products that contain ibuprofen, na ...
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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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