• Study Resource
  • Explore Categories
    • Arts & Humanities
    • Business
    • Engineering & Technology
    • Foreign Language
    • History
    • Math
    • Science
    • Social Science

    Top subcategories

    • Advanced Math
    • Algebra
    • Basic Math
    • Calculus
    • Geometry
    • Linear Algebra
    • Pre-Algebra
    • Pre-Calculus
    • Statistics And Probability
    • Trigonometry
    • other →

    Top subcategories

    • Astronomy
    • Astrophysics
    • Biology
    • Chemistry
    • Earth Science
    • Environmental Science
    • Health Science
    • Physics
    • other →

    Top subcategories

    • Anthropology
    • Law
    • Political Science
    • Psychology
    • Sociology
    • other →

    Top subcategories

    • Accounting
    • Economics
    • Finance
    • Management
    • other →

    Top subcategories

    • Aerospace Engineering
    • Bioengineering
    • Chemical Engineering
    • Civil Engineering
    • Computer Science
    • Electrical Engineering
    • Industrial Engineering
    • Mechanical Engineering
    • Web Design
    • other →

    Top subcategories

    • Architecture
    • Communications
    • English
    • Gender Studies
    • Music
    • Performing Arts
    • Philosophy
    • Religious Studies
    • Writing
    • other →

    Top subcategories

    • Ancient History
    • European History
    • US History
    • World History
    • other →

    Top subcategories

    • Croatian
    • Czech
    • Finnish
    • Greek
    • Hindi
    • Japanese
    • Korean
    • Persian
    • Swedish
    • Turkish
    • other →
 
Profile Documents Logout
Upload
Pharmacokinetics for the Non-Specialist
Pharmacokinetics for the Non-Specialist

... rate. At the point of Cmax, these two rates are equal and after this the elimination rate is greater than the absorption rate. Eventually the concentration of the drug decreases and the effect diminishes. ...
Transdermal Drug Patches to 2020 Brochure
Transdermal Drug Patches to 2020 Brochure

... Transdermal drug patches offer the advantages of ease of use, painlessness, disposability, control of drug delivery and avoidance of first-pass metabolism by the liver. Advances in synthetic materials and patch design have led to patches that are more esthetically acceptable and that are capable of ...
Pharmaceutical pricing in France: a critique
Pharmaceutical pricing in France: a critique

... prescription. It is critical therefore that all ...
Core Concepts in Pharmacology
Core Concepts in Pharmacology

... • ciprofloxacin hydrocholride (Cipro) has a halflife of 4 hours. • You administer a 500 mg oral dose of ciprofloxacin. How long will it take to have less than 1o mg of that dose circulating? ...
1st and 2nd Lectures
1st and 2nd Lectures

... in the same area, or from drugs already in clinical use? iii. Is it likely that an esoteric drug delivery system will be required, and if so, can this be developed? iv. If the drug is successfully developed, is the expected market sufficient to justify the cost of development? ...
Manuscript "Fast-track drug approval in inflammatory bowel diseases"
Manuscript "Fast-track drug approval in inflammatory bowel diseases"

... criteria for fast track review and what would the outcome have been if they had been subject to this process This is a very interesting question. The following statement was added in our manuscript. “An interesting question would be whether the currently -or soon to be- approved IBD drugs would have ...
Herbal Supplements:
Herbal Supplements:

Mineral Oil and Placebo Inertness Issue
Mineral Oil and Placebo Inertness Issue

... obtained   from   petroleum,   which   do   not   contain   any   functional   groups   (e.g.,   no   carboxyl   groups     in   contrast   with   fatty   acids   in   vegetable   oils)   and   are   considered   chemically   inert   with   ...
Revised: November 2016 Amended pages SUMMARY OF
Revised: November 2016 Amended pages SUMMARY OF

... During the period of expected efficacy (i.e. one week after treatment), ticks will be killed and fall off the host within 48 hours after infestation without having had a blood meal as a rule but an attachment of single ticks after treatment cannot be excluded. A transmission of infectious diseases b ...
Transdermal Delivery Systems
Transdermal Delivery Systems

... The stratum corneum is the outermost layer of the epidermis and is composed mainly of dead cells that lack nuclei. These are sloughed off during the day and replaced by new cells from the stratum germinativum. There is a high proportion of keratin, an insoluble protein, with a high proportion of di ...
The Drug development process
The Drug development process

... systems capable of accurate dosage 3.delivery, either in powder or liquid form; 4.levels of absorption achieved without the need to include penetration enhancers which are generally too irritating for longterm use. • Although the molecular details remain unclear, this absorption process appears to o ...
Neodecanoic Acid Product Safety Summary
Neodecanoic Acid Product Safety Summary

... belief, accurate and reliable as of the date issued. You can contact ExxonMobil to insure that this document is the most current available from ExxonMobil. Users of chemical products should refer to the product labels and applicable Material Safety Data Sheets for information and recommendations as ...
Betahistine.2HCl 16, tablets 16 mg 1.3 1.3.1 : SmPC, Labelling and
Betahistine.2HCl 16, tablets 16 mg 1.3 1.3.1 : SmPC, Labelling and

... been demonstrated in man by the abrogation of betahistine-induced vasodilation with the histamine antagonist diphenhydramine. Betahistine has minimal effects on gastric acid secretion (an H2-receptor mediated response). Mechanism of action of betahisitine in Ménière’s syndrome is unclear. The effica ...
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE

... severity, due to a lack of information on these patient populations. Because of possible reduced bioavailability, the product must not be administered in cases of prolonged or uncontrolled vomiting. Occurrence of skin reactions has been reported with the use of the product. These are in most cases m ...
Bio-identical Hormone Therapy: What`s the Harm?
Bio-identical Hormone Therapy: What`s the Harm?

... selling. End result: some patients won’t get these meds No pharmacy has $800K lying around to invest in an NDA application or the millions it will take to do clinical trials to prove they are safe and effective Pharmacy compounding could cease to exist FDA will likely “selectively enforce” to preven ...
- Houston Livestock Show and Rodeo
- Houston Livestock Show and Rodeo

... Approved Drug Use: If an animal has been administered a drug that is FDA approved for its species and class, sufficient time must have passed so that the animal does not test positive for that drug upon arrival at NRG Park. Animals must remain free and clear of all drug and chemical residues while o ...
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE

... diarrhoea with significant vomiting or a lack of appetite In the event of serious or prolonged diarrhoea with important vomiting or a lack of appetite, intravenous rehydration should be considered. The presence of bloody or purulent stools and fever may indicate the presence of invasive bacteria as ...
Injectable formulations
Injectable formulations

... hemolysis upon injection. Sometimes it is possible to alleviate these side effects by designing a water-soluble prodrug of the lipophilic water-insoluble drug. However, a prodrug will change the pharmacokinetics of the parent drug. For example, due to the gradual metabolism of the prodrug to form th ...
Adenosine 5 ?-triphosphate disodium salt (A2383)
Adenosine 5 ?-triphosphate disodium salt (A2383)

Western Washington University Rowing Safety
Western Washington University Rowing Safety

Guide to Registration of Food-Drug Interface Products
Guide to Registration of Food-Drug Interface Products

One of These Things Is Not Quite the Same: A Comparison of the
One of These Things Is Not Quite the Same: A Comparison of the

... conditions under which ANDAs are permitted. This paper presents an overview of these two areas, followed by a comparison that considers their similarities and differences from theoretical and practical perspectives. ...
Drug - NLE
Drug - NLE

... result of competing for absorption mechanism, metabolic route, chemical reaction between the drugs or pharmacodynamic; similar or opposing mechanisms at site of action lead to increased or decreased effects. Adverse reactions increase with numbers of drugs taken; 7% incidence in patients taking 6-10 ...
IntelGenx Technologies Corp. (Form: 8-K, Received
IntelGenx Technologies Corp. (Form: 8-K, Received

... Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx' actual results could differ materially from those expressed or implied by these forward looking statements. Factors that could cause or contribute to such differences include, but are not limited ...
My  name  is  Dr.  Robert ... Health  Networks  Inc.  based  in ...
My name is Dr. Robert ... Health Networks Inc. based in ...

... can easily self diagnose allergic rhinitis and treat the condition with relative ease. This self-diagnosis and treatment is performed by millions of Americans daily, with the current complement of OTC antihistamines available. The third criteria, safety, is also satisfied since hundreds of randomize ...
< 1 ... 160 161 162 163 164 165 166 167 168 ... 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.
  • studyres.com © 2025
  • DMCA
  • Privacy
  • Terms
  • Report