• Study Resource
  • Explore
    • 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
Get expert answers by video or live chat valsartan 80 mg costo
Get expert answers by video or live chat valsartan 80 mg costo

(MEDEL Combined) without criteria - August 2012
(MEDEL Combined) without criteria - August 2012

(MEDEL Combined) without Criteria
(MEDEL Combined) without Criteria

... J. Drug-specific PA Forms- Drug-specific PA forms contain medical necessity documentation requirements and/or criteria that may not be repeated in the PDL. Drug-specific PA forms may be obtained on the web at www.mainecarepdl.org . K. PA Exemptions for Prescribers- According to MaineCare Benefits Ma ...
(MEDEL Combined) without criteria-November 2013
(MEDEL Combined) without criteria-November 2013

... J. Drug-specific PA Forms- Drug-specific PA forms contain medical necessity documentation requirements and/or criteria that may not be repeated in the PDL. Drug-specific PA forms may be obtained on the web at www.mainecarepdl.org . K. PA Exemptions for Prescribers- According to MaineCare Benefits Ma ...
Extract from the Clinical Evaluation Report for Sofosbuvir
Extract from the Clinical Evaluation Report for Sofosbuvir

... For the most recent Product Information (PI), please refer to the TGA website . ...
Extract from the Clinical Evaluation Report for Sofosbuvir
Extract from the Clinical Evaluation Report for Sofosbuvir

... For the most recent Product Information (PI), please refer to the TGA website . ...
Ibuprofen: Pharmacology, Therapeutics and Side Effects
Ibuprofen: Pharmacology, Therapeutics and Side Effects

... As detailed in this book, ibuprofen has since been proven to be one of the safer NSAIDs. This is such that it has been used extensively as a standard for comparison in the large number of clinical trials of newly developed agents. These trials are reviewed here, and although some newer drugs (e.g., ...
The Proton Pump Inhibitor, Omeprazole, but Not Lansoprazole or
The Proton Pump Inhibitor, Omeprazole, but Not Lansoprazole or

... omeprazole does cause clinically significant inhibition of CYP2C19. This apparent discrepancy could be explained if omeprazole, but not lansoprazole, were an irreversible inhibitor of CYP2C19. In support of this possibility, we presented preliminary in vitro evidence for metabolism-dependent inhibit ...
Safety Assessment of Alumina and Aluminum Hydroxide
Safety Assessment of Alumina and Aluminum Hydroxide

... are all kinds of gels and pH adjusters and things like that, which I mean, yes, they are, or they can be. MR. ANSELL: What would be the concern about the aluminum ion? DR. SHANK: None for me, but then you should have to discuss breast cancer and Alzheimer's because the literature is full of that con ...
Report on the Deliberation Results August 25, 2009 Evaluation and
Report on the Deliberation Results August 25, 2009 Evaluation and

... It is concluded that the submitted data have demonstrated the efficacy and safety of the product in type 2 diabetes mellitus. The efficacy of the product has been shown in phase III clinical studies (P054, P055, ONO-5435-08 to -10) etc. No major safety problems have been identified in phase III clin ...
ziprasidone - PsychSearch
ziprasidone - PsychSearch

... 1) For BIPOLAR MANIA, the recommended initial dose is 40 milligrams twice daily with food. On the second day of treatment, the dose should be increased to 60 or 80 milligrams twice daily and thereafter adjusted according to tolerance and efficacy within the range of 40 to 80 milligrams twice daily. ...
Biopharmaceutical considerations and in vitro
Biopharmaceutical considerations and in vitro

... Dedicated staffs of Department of Pharmacy and Pharmacology University of Bath: Ms ...
a contemporary history of ibogaine in the united states and europe
a contemporary history of ibogaine in the united states and europe

... intimates a relationship of public opinion to regulatory scientific policy. The statement was made at a time when the FDA, partly in response to highly motivated and organized public advocacy, was modifying its drug development process to accommodate the more rapid evaluation and approval of agents ...
FOP - The IFOPA
FOP - The IFOPA

... Chest Pain Drug a No-Go for FOP: A Small Clinical Trial From Nagoya, Japan . . . . . . . . . . . . . . . . . . . . . . . . . Do Narcotics Enhance FOP Lesion Formation? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . What’s the FOP Mutation Doing Ther ...
Safety Assessment of Alumina and Aluminum Hydroxide as Used in
Safety Assessment of Alumina and Aluminum Hydroxide as Used in

... But this could be dealt with in the introduction that this report is on alumina which it's chemically defined as such and such and not on aluminum or aluminum compounds which nevertheless have attracted tremendous interest because of other toxicities and health concerns. The panel considered this li ...
SEVOFLURANE
SEVOFLURANE

... without jaundice have been reported in association with sevoflurane from post-marketing experiences. As with other halogenated anesthetics, sevoflurane may cause sensitivity hepatitis in patients who have been sensitized by previous exposure to halogenated anesthetics (especially when the exposure i ...
Bioavailability & Bioequivalence
Bioavailability & Bioequivalence

... restricted to the proximal tubules  Reabsorption occurs all along the nephron; Active reabsorption usually occurs in the proximal tubule  Appearance of drug in the urine is the net result of filtration, secretion, and reabsorption ...
Milk and Dairy Beef Drug Residue Prevention
Milk and Dairy Beef Drug Residue Prevention

... virginiamycin, and tripelennamine. Some testing laboratories have modified this method to include additional drugs. ...
Inhaled nicotine replacement therapy
Inhaled nicotine replacement therapy

... In contrast, a variety of electronic nicotine delivery devices such as e-cigarettes are already available in many countries which provide an alternative to cigarettes and a potentially ‘safer’ way to inhale nicotine. These devices are promoted specifically without clinical data demonstrating that th ...
Fourth_amended_complaint_restricted.pdf1165439753581
Fourth_amended_complaint_restricted.pdf1165439753581

Gemcitabine 1g Powder for Solution for Infusion
Gemcitabine 1g Powder for Solution for Infusion

... No new studies have been performed by the applicant. The applicant’s dossier states that products containing gemcitabine hydrochloride have been used in humans for about 15 years. Gemcitabine was first synthesized in the 1980s and put to clinical use in the 1990’s. The clinical overview discusses st ...
Milk and Dairy Beef Drug Residue Prevention
Milk and Dairy Beef Drug Residue Prevention

Amphotericin B as a mycolic acid specific targeting agent in tuberculosis
Amphotericin B as a mycolic acid specific targeting agent in tuberculosis

... I would humbly like to thank the following individuals and organizations for their support towards my completion of my MSc. degree. Most importantly, our Creator and King, for the guidance and support in the good and trying times and never leaving my side. Prof. J.A. Verschoor my promoter, for his d ...
A Closer Look at the Risks vs. Benefits of Kava (Piper methysticum)
A Closer Look at the Risks vs. Benefits of Kava (Piper methysticum)

Australian public assessment report for Dolutegravir (as sodium)
Australian public assessment report for Dolutegravir (as sodium)

... transcriptase inhibitors (RTI). More recently, INIs have been introduced. As a new class of antiretroviral therapy (ART), INIs block the action of the integrase (IN) viral enzyme required for HIV replication. Two INIs, raltegravir (RAL) and elvitegravir (EVG), have proved effective and have been app ...
1 2 3 4 5 ... 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