• 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
AP
AP

... APPMA is al process can be developed that will protect the drug appr th, provide assurance of drug efficacy, and provide public he rs of drugs with the ability to develop and market manufactu This will in turn benefit ffective treatments. safe and American c nsumers by providing them with a wider ra ...
NH3 N]ammonia
NH3 N]ammonia

... Injection for intravenous use. The NIH clinical trials registry (www.clinicaltrials.gov) should be consulted for a list of current trials using 13Nammonia. As of December 2012, three clinical trials were listed for the United States, only one that was still accruing patients. The best reference at t ...
Pharmacy Newsletter - Gold Coast Health Plan
Pharmacy Newsletter - Gold Coast Health Plan

... medication management is the primary means of treating this disease. For GCHP, anti-asthmatic medications are sixth among the prescriptions filled in all therapeutic classes. This is good, but we could do better. The results of our 2015 Healthcare Effectiveness Data and Information Set (HEDIS®), sho ...
My Big Data Experience - Getting my Feet Wet in the PUddle and Still Treading Water 2 Years Later
My Big Data Experience - Getting my Feet Wet in the PUddle and Still Treading Water 2 Years Later

... that country yet then there are a couple of approaches that can be taken. We can run cost/benefit ratios of the current market using data for the current standard of care and then forecast how the drug would fit into this based on clinical evidence. We can also, if possible, run cost/benefit analysi ...
Orphan Medicinal Products 2000 - 2004
Orphan Medicinal Products 2000 - 2004

... – With reference to authorised methods, sponsor should provide justification for the assumption that the medicinal product for which designation is sought will be of ‘significant benefit’ to those affected by the condition ...
Commentary
Commentary

... has requested an Rx-to-OTC switch-the FDA meeting received much attention and reaction from the press, consumer groups, medical societies, and professional associations, as well as from the pharmaceutical industry. The only other recent instance of an Rx-to-OTC switch initiated by a party other than ...
PRINCIPLES OF PHARMACOLOGY
PRINCIPLES OF PHARMACOLOGY

... reaching the systemic circulation as intact drug. Bioavailabilty is highly dependent on both the route of administration and the drug formulation. ...
Drug Metabolism and Pharmacokinetics in Drug Discovery: A Primer
Drug Metabolism and Pharmacokinetics in Drug Discovery: A Primer

Presentation
Presentation

...  Designed and selected the appropriate models, dosing regimens, and showed how they can be used to investigate the in vivo pharmacodynamic properties of developmental drugs against a selection of multi-resistant Gram-negative organisms  Profiled BAL30072 in vitro and in vivo against MDR bacteria i ...
Document
Document

... • New York Academy of Sciences, Feb 2003 • Oxygen Club of California, Feb 2003 and Feb 2004 • FASEB/American Society of Nutritional Sciences - April 2003 and April 2004 ...
Basic concepts of pharmacokinetics
Basic concepts of pharmacokinetics

Document
Document

A novel signal detection algorithm for identifying hidden drug
A novel signal detection algorithm for identifying hidden drug

... The Food and Drug Administration (FDA) has been collecting adverse drug event reports from clinicians, patients, and drug companies for over 30 years. Over two million of these reports describe patients with adverse events who are on two or more drugs. Health Canada and the WHO also maintain large d ...
J.P. MORGAN 34TH ANNUAL HEALTHCARE CONFERENCE
J.P. MORGAN 34TH ANNUAL HEALTHCARE CONFERENCE

The Emperor`s New Drugs: An Analysis of Antidepressant
The Emperor`s New Drugs: An Analysis of Antidepressant

... In clinical trials, the effect of the active drug is assumed to be the difference between the drug response and the placebo response. Thus, the FDA clinical trials data indicate that 18% of the drug response is due to the pharmacological effects of the medication. This is based on LOCF data, in whic ...
Practical Pharmacokinetics for the Bedside Clinician
Practical Pharmacokinetics for the Bedside Clinician

... discharge counseling. What considerations might you take into account? A. MA is giving up smoking and therefore will be more sensitive to the effects of caffeine B. MA may be at risk of stent thrombosis secondary to suboptimal therapy from the antiplatelets she has been prescribed C. Both of the abo ...
Antihistamines and Allergic Emergencies
Antihistamines and Allergic Emergencies

... RESERVOIRS Free ...
general_pharmacology
general_pharmacology

...  The glass container should be neutral as not react with drug.  The contents are usually liquid but may be in powder form to dissolve immediately before use.  They may be dispensed in (ampulse) containing single doses of drugs, or vials which are rubber capped bottles containing a number of doses ...
CorkMaternityNovembe
CorkMaternityNovembe

The Handbook of Clinically Tested Herbal Remedies
The Handbook of Clinically Tested Herbal Remedies

... the evidence for these herbs. I inquired what language that might be and he replied, “double-blind, controlled, randomized clinical trials.” My response was that quite a few studies have been conducted on herbal remedies, probably more than he realized. Thus, the idea of this book was born. Purpose ...
AusPAR: Sevelamer hydrochloride
AusPAR: Sevelamer hydrochloride

Half-life of a drug
Half-life of a drug

... The volume of distribution is not an actual volume, since its estimation may result in a volume greater than the volume available in the body (~40 L in a 70-kg adult). Such a value will result if the compound is bound or sequestered at some extravascular site. For example, a highly lipidsoluble drug ...
Marketed products fact sheet
Marketed products fact sheet

... OUR SPECIALTY PRODUCTS Actelion is creating specialty franchises alongside PAH – discovering, developing and/or in‑licensing/acquiring products in new therapeutic areas. ...
General Pharmakokinetics
General Pharmakokinetics

... Placental barrier. Placental membranes are lipid and allow free passage of lipophilic drug, while restricting hydrophilic drugs. The placental P-gp also serves to limit foetal exposure to maternally administered drugs. However restricted amounts of nonlipid soluble drugs, when present in high conce ...
lecture 4
lecture 4

... • Name suggests three components – Antibody • Allows for specific detection of analyte of interest ...
< 1 ... 75 76 77 78 79 80 81 82 83 ... 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