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The use of microbiological end-points in the safety evaluation and
The use of microbiological end-points in the safety evaluation and

... studies are expensive and of unknown sensitivity (Corpet, 1993). Studies can be made of biomarkers of bacterial metabolic activity (Midtvedt, 1986). These are generally studies of bacterial enzyme activity such as nitrate reductase or the 7-a-dehydroxylation of bile acids but the relationships of th ...
epanova
epanova

... Literature Review • Discussion: • Epanova reduced TG levels by at least ...
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1

... Bedaquiline has minor influence on the ability to drive and use machines. Adverse reactions, such as dizziness, may affect the ability to drive or use machines. Patients should be advised not to drive or operate machinery if they experience dizziness while taking SIRTURO. ...
09107sgp04ppt
09107sgp04ppt

... xinafoate induced merciful tumors of smooth muscle in the mesovarium of rats and the uterus of mice • salmeterol is not considered to cause a significant hazard to man. • Clinical Research---- similar study was taken on human → Result: no clinically relevant serious adverse cardiac effects have been ...
Should My Loved One Be Taking the Alzheimer`s Medicines?
Should My Loved One Be Taking the Alzheimer`s Medicines?

... Researchers and a number of neurologists have recommended that patients with Alzheimer’s take one of the medicines for early stage and the medicine for middle stage together (during the same day), if they can tolerate the side effects of the medicines. The most common side effects of these medicines ...
and drug
and drug

... Be courteous of your fellow students. You may come in late, leave early, sleep, eat, drink, read the newspaper, text message your friends, listen to your iPod, … Just do it quietly and do not disturb other students who are trying to pay attention to the lecture. ...
Body mass index predicts discontinuation due to ineffectiveness and
Body mass index predicts discontinuation due to ineffectiveness and

... but not split for different biologics or for the reason of discontinuation. Objectives To compare long-term drug survival between the outpatient biologics adalimumab, etanercept and ustekinumab in patients with psoriasis, and to elucidate predictors for overall survival and drug discontinuation due ...
O DUR B N
O DUR B N

... Carisoprodol has limited efficacy in the short-term and is not effective for the treatment of chronic pain. No evidence exists for a clinically significant effect other than sedation.1 In addition, carisoprodol is associated with dependence when used on a long-term basis. This lack of efficacy and p ...
Revised: January 2016 AN. 01318/2015 SUMMARY OF PRODUCT
Revised: January 2016 AN. 01318/2015 SUMMARY OF PRODUCT

... Absorption: The methylxanthines are readily absorbed following oral administration. Studies in man have shown that the administration of theophylline with food may slow but not reduce absorption of the drug, and help avoid local irritation of the gastro-intestinal tract. In the absence of food, theo ...
`Let Them Eat Prozac` - Introduction: The SSRI Issues
`Let Them Eat Prozac` - Introduction: The SSRI Issues

ISMP Medication Safety Alert
ISMP Medication Safety Alert

... thefollowing selected items fromtheApril-June 2009 ISMPMedication Safety Alert! havebeen prepared for an interdisciplinary committeeto stimulatediscussion and action toreducetherisk of medication errors. Each itemincludes a description of themedication safety problem, recommendations toreducetherisk ...
Introduction - Let them Eat Prozac
Introduction - Let them Eat Prozac

... antipsychotic, remoxipride, which looked like it would have significantly fewer side effects than older agents. Several months after its launch, however, remoxipride was reported to cause aplastic anemia in a small number of people and it too was withdrawn. In the face of this series of setbacks, As ...
#29768 29768 Ultralyx® Wheat Pasture Mineral with Bloat Guard
#29768 29768 Ultralyx® Wheat Pasture Mineral with Bloat Guard

Frequently Asked Questions on Potassium Iodide (KI)
Frequently Asked Questions on Potassium Iodide (KI)

... provide guidance to other Federal agencies, including the Environmental Protection Agency (EPA) and  the Nuclear Regulatory Commission (NRC), and to state and local governments regarding the safe and  effective use of potassium iodide (KI) as an adjunct to other public health protective measures in  ...
Antibody-Drug Conjugates (ADCs) – Biotherapeutic bullets
Antibody-Drug Conjugates (ADCs) – Biotherapeutic bullets

I`ve heard that I should not consume grapefruit products while taking
I`ve heard that I should not consume grapefruit products while taking

... CPS (Compendium of Pharmaceuticals and Specialties with eTherapeutics) ...
View press release  doc - 79 KB
View press release doc - 79 KB

CV Strategy Research
CV Strategy Research

FREE Sample Here - We can offer most test bank and
FREE Sample Here - We can offer most test bank and

... Which precaution is most important for the nurse to teach? a. “Drugs in this category reduce the effectiveness of oral contraceptives and you will need to switch to another form of birth control to prevent pregnancy.” b. “One side effect of drugs in this category is nausea, which will make morning s ...
Rosuvastatin Stada 5 mg film-coated tablets Rosuvastatin
Rosuvastatin Stada 5 mg film-coated tablets Rosuvastatin

... Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy. Symptoms can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected a patient has developed interstitial lu ...
DEVELOPMENT & VALIDATION OF STABILITY INDICATING HPLC METHOD FOR  DETERMINATION OF SOLIFENACIN IN BULK FORMULATIONS 
DEVELOPMENT & VALIDATION OF STABILITY INDICATING HPLC METHOD FOR  DETERMINATION OF SOLIFENACIN IN BULK FORMULATIONS 

... Peak  area  of  Solifenacin  was  plotted  versus  their  respective  concentrations  and  linear  regression  analysis  performed  on  the  resultant curves. Correlation coefficient was found to be more  than  ...
Pharmacokinetics and Pharmacodynamics for Medical Students: A
Pharmacokinetics and Pharmacodynamics for Medical Students: A

... of unwanted drug effects. However the path to pharmacodynamics comes via pharmacokinetics. Because drug effects are related to drug concentrations, understanding and predicting the time course of concentrations can be used to help optimize therapy. The link of drug dosage to drug effect involves a s ...
C h a p t e r 1 8 Chirally Pure Drugs in Hypertension
C h a p t e r 1 8 Chirally Pure Drugs in Hypertension

A Systematic Review and Meta-Analysis of the Efficacy of Piracetam
A Systematic Review and Meta-Analysis of the Efficacy of Piracetam

John Wang
John Wang

< 1 ... 67 68 69 70 71 72 73 74 75 ... 193 >

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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