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dshea`s failure: why a proactive approach to dietary supplement
dshea`s failure: why a proactive approach to dietary supplement

... have caused numerous illnesses and deaths. Under DSHEA manufacturers are required to report certain facts to the FDA, such as whether a new dietary ingredient is reasonably expected to be safe. Additionally, manufacturers are required to report serious adverse events associated with a dietary supple ...
10.4103_0975-1483.63169
10.4103_0975-1483.63169

Evaluation of Quality Control Parameters of Two Brands of
Evaluation of Quality Control Parameters of Two Brands of

Potential Drug Interactions with Grapefruit Evidence and Advice You Can Trust... CHART: CHART
Potential Drug Interactions with Grapefruit Evidence and Advice You Can Trust... CHART: CHART

... In addition to grapefruit juice, many researchers are warning that the fruit itself could also cause problems. Several studies now indicate that the fruit should also be avoided in patients taking interacting drugs. 42-44 Health Canada is now advising consumers NOT to drink grapefruit juice or eat g ...
APhA BOOKS AND ELECTRONIC PRODUCTS 2014
APhA BOOKS AND ELECTRONIC PRODUCTS 2014

... Motivational Interviewing for Health Care Professionals: A Sensible Approach presents a new way of teaching the theory and practice of motivational interviewing (MI) to health care professionals (HCPs). MI has been shown to improve treatment adherence and outcomes, promote health behavior change, im ...
Dear Sir/Madam - University of Michigan College of Pharmacy
Dear Sir/Madam - University of Michigan College of Pharmacy

... ADME comparison of macro- and small-molecules. Invited oral presentation at East China University of Science and Technology, Shanghai China, May 2012. ...
safety data sheet - Nephron Pharmaceuticals Corporation
safety data sheet - Nephron Pharmaceuticals Corporation

Glutenza - theDr.com
Glutenza - theDr.com

... are sensitive to their specific environment, and are only active in the large intestine. The result of extensive research, PreForPro™ is a highly specialized prebiotic that is not fiber or starchbased and solves the problems plaguing traditional prebiotics. PreForPro™ does not cause flatulence, is e ...
Submission Guidelines for the CADTH Common Drug Review
Submission Guidelines for the CADTH Common Drug Review

... Common Drug Review (CDR) process. The Submission Guidelines for the CADTH Common Drug Review is a companion document to the Procedure for the CADTH Common Drug Review, a document that describes CDR procedures to be followed by all participants involved in the CDR process. The Submission Guidelines f ...
Assessment report on Vitex agnus-castus L., fructus
Assessment report on Vitex agnus-castus L., fructus

... Vitex agnus-castus, which grows in the region of the Mediterranean Sea, is a shrub which belongs to the Verbenaceae plant family. The medicinal plant was already mentioned by Dioscurides, a famous pharmacologist of the antiquity. “Agnós” as well as “castus” means “chaste”. The plant, respectively it ...
Japanese Guideline on the Investigation of Drug Interactions, 2014
Japanese Guideline on the Investigation of Drug Interactions, 2014

... oral route should be studied with reference to this guideline, bearing in mind the fact that the degree of ...
Safe and Secure Handling of Medicines Within
Safe and Secure Handling of Medicines Within

... This document is available on the NHS GGC StaffNet and NHS GGC Prescribing website. It is correct at time of first issue but the online version will be reviewed and updated on a regular basis in response to further guidance or changes in legislation. If versions of this document are printed and stor ...
19 Improving  the  Oral  Absorption  of S-SEDDS Formulations
19 Improving the Oral Absorption of S-SEDDS Formulations

... drug microemulsion with a particle size 150 nm and, preferably, as low as 10–20 nm. By this definition the term SEDDS includes all other self-emulsify formulations that contain a surfactant and a lipid, such as SNEDDS or SMEDDS. The term, SEDDS, based on the above definition includes “self-emulsif ...
Albuterol Sulfate Inhalation Solution 0.083%
Albuterol Sulfate Inhalation Solution 0.083%

... The following adverse effects have been reported with medicinal use of Albuterol Sulfate Inhalation Solution, 0.083% and may accompany unintentional exposure in sufficient dose: fine muscle tremors, muscle cramps, nausea/vomiting, headache, dizziness, nervousness, heartburn, and rapid pulse, palpita ...
Emtricitabine / rilpivirine / tenofovir disoproxil fumarate
Emtricitabine / rilpivirine / tenofovir disoproxil fumarate

IMPURITIES IN PHARMACEUTICALS
IMPURITIES IN PHARMACEUTICALS

... The specifications for a new substance should include limits for impurities. Stability studies, chemical development studies, and routine batch analyses can be used to predict those impurities likely to occur in the commercial product. The selection of impurities to include in the new substance spec ...
Claim Interpretation part I
Claim Interpretation part I

PART II - Chanelle Group
PART II - Chanelle Group

... occult blood, loss of appetite and lethargy have been reported. These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal. If adverse reactions occur, use ...
Acetaminophen
Acetaminophen

... increases the absorption of acetaminophen (Felleskatalogen [online]). ...
overview of comments received on community - EMA
overview of comments received on community - EMA

... standard antidepressants authorized for the treatment of major depression, including moderate depression, leads to the conclusion, that moderate depressive episodes are a necessary part of the therapeutic indication. With respect to the qualitative and quantitative composition, a limitation of well ...
Word - corporate
Word - corporate

... hemoglobin polymerization, the underlying mechanism of RBC sickling. In our clinical trials of GBT440 in SCD subjects, we observed reduced markers of red blood cell destruction, improvements in anemia, improvements in markers of tissue oxygenation, reduced numbers of sickled RBCs, and reduced marker ...
LIDOCAINE VISCOUS 2%
LIDOCAINE VISCOUS 2%

... Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. These changes may be attributable to a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system. The net effect is normally a modest h ...
Name of Herb: Aloe
Name of Herb: Aloe

... The second product, aloe gel, is the clear, jelly-like material from the sticky cells found in the inner tissue of the leaf. It generally doesn’t contain the anthraquinone glycosides found in the latex but does contain the polysaccharides glucomannan and acemannan Other potentially active components ...


... formulations are expected to be approved over the next few years. These formulations will undoubtedly be the subject extensive sales,marketing and physician sampling efforts, particularly in view of the void created by the recent withdrawal of Vioxx@ and Bextra@,and the genericization of Ultram@,Ult ...
Antibody–drug conjugates nonclinical support: from early to late
Antibody–drug conjugates nonclinical support: from early to late

... where research teams are working with large number of similar compounds for a given target, the availability of critical reagents, time and resources may be limited. As a result, flexible ‘fit-for-purpose’ assay development approaches and generic reagents against human IgG, or Fc region or (Fab’)2 r ...
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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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