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Investor FactBook - FY 2014 results27-February
Investor FactBook - FY 2014 results27-February

... As for our commercial strategy, we have our own presence covering specialist physicians, payers and patient groups, in North America, Europe and major emerging markets. In all areas, we continue to learn from best-in-class companies outside the biopharma industry in areas such as innovation, custome ...
drug interactions - Liverpool John Moores University
drug interactions - Liverpool John Moores University

... • Not strongly protein bound ...
Extemporaneous formulations-problems and solutions
Extemporaneous formulations-problems and solutions

annexure – ii
annexure – ii

... transport across a biological membrane, is the product of permeability and solubility. According to the biopharmaceutics classification system (BCS), aqueous solubility and permeability are the most important parameters affecting drug bioavailability. Retrospective studies show that greater than 40% ...
HW Lesson 36
HW Lesson 36

... registered name or trademark given to it by a pharmaceutical company. – A generic-name drug is a drug that contains the same active ingredients as a brand-name drug. – Generic and brand names of a particular drug usually have therapeutical equivalence, which means two drugs are chemically the same a ...
7. Calculation of Doses- General considerations.ppt [相容模式]
7. Calculation of Doses- General considerations.ppt [相容模式]

Biophytis presents preliminary clinical data of SARA
Biophytis presents preliminary clinical data of SARA

... biotechnology company specializing in the development of drug candidates to treat diseases of ageing, announced today that new preclinical and clinical data on Sarconeos (BIO101), the Company’s lead drug candidate in the treatment of Sarcopenia, have been presented at the 9th International Conferenc ...
Full Text Article
Full Text Article

Dependence, Tolerance, and Addiction to Benzodiazepines: Clinical
Dependence, Tolerance, and Addiction to Benzodiazepines: Clinical

... A common example involves the acute intoxicant effects of ethyl alcohol. The alcohol concentration in the blood (and presumably also a t the receptor site in the brain) following acute ingestion of ethanol may be higher during recovery from acute intoxication than earlier when subjective manifestati ...
Standard 1: The pharmacy manager will ensure that nonprescription
Standard 1: The pharmacy manager will ensure that nonprescription

... 1. Are considered to be within the professional practice of pharmacy, regulated by provincial regulatory authorities in accordance with guidelines and standards that ensure the quality and safety of pharmaceuticals; 2. Involve a relationship that can be demonstrated to exist between a patient and/or ...
SECTOR OVERVIEW OCULAR DRUG DELIVERY TECHNOLOGIES
SECTOR OVERVIEW OCULAR DRUG DELIVERY TECHNOLOGIES

... every 4-8 weeks. Therefore, achieving sufUS have diagnosed AMD, with this number ficiently high concentrations at the target expected to double to nearly 22 million by site and maintaining these over prolonged 2050. Worldwide around 18 million injecperiods with minimal side effects, offers tions of ...
Developmental Pharmacology — Drug Disposition, Action, and
Developmental Pharmacology — Drug Disposition, Action, and

... nfants and children are far different from adults in terms of societal, psychosocial, behavioral, and medical perspectives. More than 100 years ago Dr. Abraham Jacobi, the father of American pediatrics, recognized the importance of and need for age-appropriate pharmacotherapy when he wrote, “Pediatr ...
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. ...
Updates in Pharmacotherapy
Updates in Pharmacotherapy

...  http://www.aricnews.net/riskcalc/html/RC1.html  http://www.diabetes.org/phd ...
NSW TAG Off-Label Use of Registered Drugs and Drugs
NSW TAG Off-Label Use of Registered Drugs and Drugs

Levorphanol Tartrate
Levorphanol Tartrate

Principles of Clinical Trials Introduction and Learning Objectives
Principles of Clinical Trials Introduction and Learning Objectives

... • Evaluate pharmacokinetics and pharmacodynamics ...
An Overview of Setting Occupational Exposure Limits
An Overview of Setting Occupational Exposure Limits

... traditional NOEL/SF approach described above. This approach cannot be used indiscriminately, however, for several reasons. First, is the drug administered by the inhalation route, the route by which workers are exposed occupationally and for which an OEL is intended? If not, then one must consider t ...
ASEAN Variation Guidelines For Pharmaceutical Products
ASEAN Variation Guidelines For Pharmaceutical Products

... Revision of European Pharmacopoeial Certificate of Suitability (CEP) of drug substance Change of batch size of non-sterile drug product Reduction or removal of overage Qualitative or quantitative change of excipient Quantitative change in coating weight of tablets or weight and/or size of capsule sh ...
Stieprox - GlaxoSmithKline
Stieprox - GlaxoSmithKline

Lesson 36
Lesson 36

... registered name or trademark given to it by a pharmaceutical company. – A generic-name drug is a drug that contains the same active ingredients as a brand-name drug. – Generic and brand names of a particular drug usually have therapeutical equivalence, which means two drugs are chemically the same a ...
Available
Available

... 2. When method of residuals is used to determine Ke and Ka,the terminal phase of oral Absorption curve is represented by elimination rate constant and absorption rate Constant is represented by residual curve ie Ka>> Ke.In drugs showing fast eliminAtion,Ke>>Ka.For such drugs likesalicyluric acid, te ...
gau psychotropic medication guidelines
gau psychotropic medication guidelines

The Hollow Fiber Infection Model for
The Hollow Fiber Infection Model for

... subpopulations and found that different targets for the area under the concentration-time curve over 24h/MIC ratio were required for different bacteria. The data from the hollow fiber two-compartment model can be critical for determining dosage profiles and drug combinations that can prevent the eme ...
Silymarin Product Detail Sheet
Silymarin Product Detail Sheet

... while still managing their own clinical practices, plus we consult with an advisory board of health care professionals from around the world. Our products are made using only the highest quality ingredients which are extensively tested for purity and potency. The MediHerb manufacturing plant operate ...
< 1 ... 65 66 67 68 69 70 71 72 73 ... 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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