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Eco-directed sustainable prescribing
Eco-directed sustainable prescribing

... Potentially effective and less-costly upstream pollution prevention approaches have long been considered imprudent and impractical simply because they might conflict with long-accepted prescribing guidelines, norms, and tenets. But these are often influenced by behaviors, customs, attitudes, and tradi ...
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 ...
August  II,2000 VIA  Fax:  301.8275562 and  Fed-Ex Attention:
August II,2000 VIA Fax: 301.8275562 and Fed-Ex Attention:

... In our opinion, compounding of bulk chemical Methacholine Chloride USP affects the potency, Due to the drug product’s hygroscopic characteristic, purity, and quali,ty of this drug product. there is significant potential for error in one or more of the steps that could affect drug safety Studies show ...
History of TYLENOL - Nancy West Communications
History of TYLENOL - Nancy West Communications

... acetaminophen. Although his research confirmed that the drug was effective against pain and fever, von Mering recommended extensive investigation into all analgesics and antipyretics. Acetaminophen was not prescribed nor studied any further until 1949 when research on chemically related drugs revive ...
FLUNIXIN - American Academy of Veterinary Pharmacology and
FLUNIXIN - American Academy of Veterinary Pharmacology and

... For treatment of endotoxemia or sepsis in horses, an intravenous dosage regimen similar to that for colicassociated pain might be used, with additional doses every six to twelve hours after the initial one, dependent on the clinical course. The dose recommendation is based on studies performed with ...
Instructions For Use
Instructions For Use

... Special care should be taken to avoid bending, twisting or damaging the implant. ...
effects of cytochrome p450 enzyme inhibitors and inducers
effects of cytochrome p450 enzyme inhibitors and inducers

pharmacy technician ce library - Minnesota Pharmacists Association
pharmacy technician ce library - Minnesota Pharmacists Association

... One important element of pharmacy practice in which technicians play a key role is making sure that the right patient receives the right drug at the right dose. However, in order to maintain patient safety, there are several calculations that pharmacy technicians must be able to perform proficiently ...
Form 10-Q
Form 10-Q

... is a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders. Zafgen is focused on developing novel therapeutics that treat the underlying biological mechanisms through the methionine aminopeptidase 2 (“ ...
A Comparison of Thermodynamic Parameters for Vinorelbine
A Comparison of Thermodynamic Parameters for Vinorelbine

... with absorbance optics and an An60 Ti rotor. Samples were spun at 5°, 15°, 25°, or 37° at appropriate speeds, and temperature was calibrated according to the method of Liu and Stafford (1995). Velocity data were collected at 278 nm and at a spacing of 0.002 cm with one average in a continuous scan m ...
Antimicrobial Pharmacokinetics and Pharmacodynamics
Antimicrobial Pharmacokinetics and Pharmacodynamics

micronization and dissolution enhancement of norethindrone
micronization and dissolution enhancement of norethindrone

... Norethindrone (or norethisterone) is a molecule used in some combined oral contraceptive pills and in some progestogen only pills. In this study, Norethindrone Oral Tablet 0.35 mg is being developed for use in therapy of premenstrual syndrome, painful periods, abnormal heavy bleeding, irregular peri ...
Influence of posture on pharmacokinetics
Influence of posture on pharmacokinetics

... circulation is greater than the first-order rate constant for gastric emptying [19]. The mean half-time for drug transfer was 6.8 ± 0.9 min in this trial, whereas the mean gastric emptying half-time was 12 min. Consequently, gastric emptying, which is predominantly pulsatile, is the ratelimiting ste ...
Diamorphine Hydrochloride BP 100 mg Lyophilisate for solution for
Diamorphine Hydrochloride BP 100 mg Lyophilisate for solution for

Quantity Dependent Sentencing Ranges, the Drug
Quantity Dependent Sentencing Ranges, the Drug

... Administrator of the DEA, pursuant to 21 U.S.C. § 811(a) and 21 U.S.C. § 812(b)(2), found that “HCPs have a high potential for abuse. The abuse potential of HCPs is comparable to the schedule II controlled substance oxycodone.” 79 Fed. Reg. 49661, 49680 (August 22, 2014). In addition, “[t]he DEA, in ...
Corrosion Control Treatment Answer Key
Corrosion Control Treatment Answer Key

... Q: If you know that your raw water pH is ≈ 6.0, which standards would you use for pH analysis? (Answer: 4.00 and 7.00 buffer solutions) Q: If your treated water pH is ≈ 8.0, which standards would you use? (Answer: 7.00 and 10.00 buffers) Q: Why not just use 4.00 and 10.0? (Answer: The calibration pr ...
Folami Osikoya - University of Colorado Denver
Folami Osikoya - University of Colorado Denver

... and continued throughout the cycle.1 Contraception1,4-5, possibly effective not FDA approved.1 Oral melatonin 40 or 50 milligrams was given once daily at night, initiated 7 days prior to interleukin-2 (induction phase) and continued throughout the cycle.1 ...
ESPACE
ESPACE

... I argue that industrial organization and institutional conditions profoundly shape business and innovation strategies, and consequently the overall innovation process. Industrial organization characterized by selective, vertical disintegration largely defines maneuvering room for small biotechnology ...
Newer Antihistamines
Newer Antihistamines

Product Information: Lisdexamfetamine dimesilate
Product Information: Lisdexamfetamine dimesilate

The CFC to HFA Transition and Its Impact on
The CFC to HFA Transition and Its Impact on

... solvents, fire suppressants, and as propellants for various aerosols in medical as well as consumer products.1 The global consumption of CFCs grew to 109 kg per year.5 In the United States alone, CFC-related goods and services reached $28 billion a year in 1990, with related jobs estimated at 700,00 ...
product information
product information

... RejuveNail Anti-fungal Nail Lacquer should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Use in lactation It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when Re ...
Ferrario A, Kanavos P, Managed entry agreements for pharmaceuticals: the European experience. EMiNet, Brussels, Belgium
Ferrario A, Kanavos P, Managed entry agreements for pharmaceuticals: the European experience. EMiNet, Brussels, Belgium

... reimbursement lists need to demonstrate that their drugs can provide additional benefit in relation to current therapies and value-for-money in order to obtain coverage. Data and the overall evidence base available at registration are often insufficient to accurately estimate the clinical and cost-e ...
World Preview 2016, Outlook to 2022
World Preview 2016, Outlook to 2022

... However, at the current run rate 2016 might only see 47 drugs approved, raising the following question: rather than being a new normal, was 2015 the peak? If this is the case then the forecast 2.8% increases in compounded annual R&D spend to 2022 might now only yield diminishing returns. The potenti ...
Hidden Dangers: Herbal and Dietary Supplement Induced
Hidden Dangers: Herbal and Dietary Supplement Induced

... purple foxglove, vincristine from Madagascar periwinkle and many others. It is estimated that 25 to 40% of modern prescription drugs contain at least one compound now or once derived from or patterned after those found in plants. Nearly 70% of antimicrobials and 50% of anticancer drugs developed in ...
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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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