• 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
LC-Tandem MS Detection of Covalent Binding of Acetaminophen to
LC-Tandem MS Detection of Covalent Binding of Acetaminophen to

... To further characterise the NAPQI-CPF product, and to enable quantification of NAPQI-CPF in patient samples, a large scale synthesis was performed. Acetaminophen (32 mg) was oxidised to NAPQI in 75 mL chloroform, as described above, and stirred vigorously for 2 hours at room temperature with 25 mg C ...
Milk and Dairy Beef Drug Residue Prevention 2012
Milk and Dairy Beef Drug Residue Prevention 2012

... antibiotics approved for dairy animals and can also be used as an educational tool and resource for the farm managers as they develop their on-farm best management practices necessary to avoid milk and meat residues. I encourage all dairy farmers to sit down with their veterinarian and all employees ...
modafinil - Awake Institute, LLC
modafinil - Awake Institute, LLC

... Provigil was approved by the FDA in the U.S. in December 1998 for the treatment of narcolepsy. The use of the drug is rapidly expanding, with more than 80 percent of the prescriptions written off-label to treat the fatigue and sleepiness associated with many other diseases, like multiple sclerosis, ...
SUMMARY OF DATA FOR CHEMICAL SELECTION BASIS OF NOMINATION
SUMMARY OF DATA FOR CHEMICAL SELECTION BASIS OF NOMINATION

... of commerce and marketed specifically to young adults to achieve a legal high (FDA, 2000). These products may be spiked with synthetic ephedrine alkaloids and combined with other stimulants such as caffeine (Bucci, 2000). One of these products, Cloud 9, was labeled as containing 650 mg of Indonesian ...
Prevention Guide - Safe Handling of Hazardous Drugs
Prevention Guide - Safe Handling of Hazardous Drugs

... Mission. The ASSTSAS is a joint, sector-based association dedicated to promoting occupational health and safety prevention and supporting health and social service sector workers and institutions through consulting services, as well as through information, training and research and development acti ...
as hydrochloride - Therapeutic Goods Administration
as hydrochloride - Therapeutic Goods Administration

... This AusPAR describes the application by the sponsor to register Striverdi Respimat as a New Chemical Entity for the proposed indication: ‘for long term, once daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including ch ...
PRODUCT MONOGRAPH UNIPHYL Theophylline Sustained
PRODUCT MONOGRAPH UNIPHYL Theophylline Sustained

... Patients who are rapid metabolizers of theophylline, such as the young, smokers and some nonsmoking adults may not be suitable candidates for once-daily dosing. In rapid metabolizers, peak to trough fluctuations in theophylline levels may be greater than desirable or result in sideeffects at the tim ...
What are the perioperative risk benefits of garlic supplementation
What are the perioperative risk benefits of garlic supplementation

... then drying and grinding them into powder (Ross et al., 2006). Garlic extract is made from whole ...
PrDALACIN* C FLAVOURED GRANULES
PrDALACIN* C FLAVOURED GRANULES

Dabigatran etexilate for the prevention of stroke in patients with
Dabigatran etexilate for the prevention of stroke in patients with

... dosed at 110 mg twice-daily was noninferior to warfarin for the prevention of stroke, but had a lower risk of bleeding. There are few commercially available assays to monitor the effects of dabigatran and there is no known antidote that can complicate the management of emergent bleeding. For selecte ...
to the Akten FAQs PDF
to the Akten FAQs PDF

PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION

... Mifegymiso is not indicated in the prepubertal population. Patients 15 to 17 years of age had similar efficacy to that seen in the adult population. More pain than expected was reported more frequently in this population, as well as diarrhea and vomiting, compared with adults (see CLINICAL TRIALS). ...
PK/PD - Physiologie et Thérapeutique Ecole Véto Toulouse (ENVT)
PK/PD - Physiologie et Thérapeutique Ecole Véto Toulouse (ENVT)

Codeine Article-31 referral - EMA
Codeine Article-31 referral - EMA

... The analgesic properties of codeine stem from its conversion in the liver to its active metabolite morphine by the hepatic microsomal enzyme system cytochrome P450 enzyme CYP2D6. The toxicity of codeine is mainly due to its opioid effects and the most common adverse reactions to codeine include drow ...


... clearance < 20 ml / min (see sections 4.2 and 5.2). There are insufficient data regarding use of cefixime in the pediatric and adolescent age group in the presence of renal insufficiency. Therefore, the use of cefixime in these patientgroups is not recommended. Renal function is to be monitored unde ...
the preparation and administration of blincyto ® brochure
the preparation and administration of blincyto ® brochure

Hydrocortisone, Hydrocortisone Acetate
Hydrocortisone, Hydrocortisone Acetate

Medicated Chewing Gum- A Mobile Oral Drug Delivery System
Medicated Chewing Gum- A Mobile Oral Drug Delivery System

... allergy, nausea, motion sickness, diabetes, anxiety, dyspepsia, osteoporosis, cough, common cold etc. Medicated chewing gums are used not only for special population groups with swallowing difficulties such as children and the elderly, but also popular amongst the young generation. Thus chewing gum ...
Diclofenac Sodium 4% Spray Gel
Diclofenac Sodium 4% Spray Gel

... Skin disorders are commonly reported. Skin: Application site reactions, rashes, pruritus and urticaria, drying, ...
CANADA - CLG.ORG
CANADA - CLG.ORG

... 29. ABILIFY was launched in the United States in or around the fall of 2002 and ABILIFY MAINTENA was launched in the United States in March 2013; 30. On October 31, 2001, non-party Otsuka Pharmaceutical Co., Ltd. submitted a New Drug Application to the United States Food and Drug Administration (“US ...
AusPAR Attachment 2: Extract from the Clinical Evaluation Report
AusPAR Attachment 2: Extract from the Clinical Evaluation Report

2nd Quarter Conference Call
2nd Quarter Conference Call

... collaborations, future performance or financial results, the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Emisphere's product candidates and the sufficiency of Emisphere's cash and other capital resources) are forward-looking st ...
Insect repellents
Insect repellents

... A drug is defined by U.S. law as any substance (other than a food or device) intended for use in the diagnosis, cure, relief, treatment, or prevention of disease or intended to affect the structure or function of the body.  A simpler but workable definition of a drug is any chemical substance that ...
- International Journal of Pharmaceutical Sciences and
- International Journal of Pharmaceutical Sciences and

... In recent years scientific and technological advancements have been made in the research and development of oral drug delivery system. The reasons that the oral route achieved such popularity may be in part attributed to its ease of administration. Over the years, patient convenience and patient com ...
Pricing and Inventories at Unlicensed Online Pharmacies
Pricing and Inventories at Unlicensed Online Pharmacies

... The advent of electronic commerce has created new challenges in regulating the distribution of certain goods, such as alcohol, weapons or prescription drugs. Online pharmacies in particular need to meet a number of licensing requirements before they can operate legally in a large number of countries ...
< 1 2 3 4 5 6 7 8 ... 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