• 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
drug interactions
drug interactions

... measurable ( modification in magnitude or duration) of the action of one drug by prior or concomitant administration of another substance (including prescription and non prescription drugs,food or alcohol) • Interactions can occur by pharmacokinetic or pharmacodynamic mechanisms ...
Brief Note on the Development of Biotechnology
Brief Note on the Development of Biotechnology

... modelling. Moreover, the comprehensive and partly quantitative data sets provide the basis for mathematical modelling and simulation of pathways and regulatory networks. The progress in computer science also provided the basis for advanced process control and automation. At this point it needs to be ...
Drug Interactions with Hormonal Contraception
Drug Interactions with Hormonal Contraception

REVIEW ARTICLE
REVIEW ARTICLE

... is associated with serious side effects & daily dosing is needed. TF was synthesized to overcome all these deficiencies. It has a potential to replace PQas a prophylactic agent. TQ acts by accumulating in food vacuole & inhibits the detoxification of haeme to haemzoin.TF via its hydroxyl metabolites ...
Efficacy of Articaine over Lidocaine – A Review
Efficacy of Articaine over Lidocaine – A Review

Microsponges as Innovative Drug Delivery Systems
Microsponges as Innovative Drug Delivery Systems

FINDING POTENTIALLY UNSAFE NUTRITIONAL SUPPLEMENTS
FINDING POTENTIALLY UNSAFE NUTRITIONAL SUPPLEMENTS

... According to the Dietary Supplement and Health Education Act (DSHEA),1 dietary supplements (often referred to as nutritional products) are intended to supplement diet, intended for oral use, contain one or more dietary ingredients or their constituents, and are labeled on the packaging as dietary su ...
Guideline on Pulmonary Arterial Hypertension - EMA
Guideline on Pulmonary Arterial Hypertension - EMA

... drug and to determine the appropriate therapeutic range including dose-concentration-response relationship. It is recommended to establish the optimal therapeutic dose before starting the confirmatory therapeutic studies. These studies could be placebo-controlled, investigating the efficacy of at le ...
Illegible Handwriting Illegible Handwriting Illegible Handwriting
Illegible Handwriting Illegible Handwriting Illegible Handwriting

... “Patient told me that’s what he takes at home!” ...
Name of the meeting
Name of the meeting

... • The protocol has been finalised • Participants have provided descriptions of their duplicate detection methodologies. • Evaluation sheet for the national centres duplicate evaluation has been agreed, as have approaches for evaluation of the impact of duplicates on signal detection. UMC are ready t ...
Improvement of Cold-Chain Management Helps Ensure
Improvement of Cold-Chain Management Helps Ensure

... attempted to elongate or otherwise increase the absorptive surface of the bowel.” In addition, she says, if intestinal failure occurs, “SBS patients may undergo a transplant. SBS accounts for ...
SAQ127_National_QUM_Indicators_V14.html
SAQ127_National_QUM_Indicators_V14.html

... An abbreviation used by a prescriber may mean something quite different to the person interpreting the prescription. Abbreviations may not only be misunderstood but can also be combined with other words or numerals to appear as something altogether unintended. Although using abbreviations may seem t ...
Drug - Anesthesiology, Pharmacology and Therapeutics
Drug - Anesthesiology, Pharmacology and Therapeutics

Off-label use of medical products in radiation therapy
Off-label use of medical products in radiation therapy

... the health, safety, or welfare of a subject, a Premarket Approval 共PMA兲 application may be required before the medical device can be marketed. Unless the medical product is exempt from FDA regulation, collection of human research data during premarket clinical trials must be performed under an Inves ...
AMPHETAMINES RATIONALE FOR INCLUSION IN PA PROGRAM
AMPHETAMINES RATIONALE FOR INCLUSION IN PA PROGRAM

... Amphetamine is a CNS stimulant and DEA schedule II drug, which is FDA approved for attention deficit hyperactivity disorder (ADHD) and narcolepsy. The exact mechanism by which amphetamines exert their action is unknown; however amphetamines are thought to block the reuptake of norepinephrine and dop ...
Memorandum
Memorandum

... This is in responseto your letter to the Food and Drug Administration (FDA) dated October 6, 1999 (received on October 20, 1999), making a submission for a new dietary ingredient pursuant to 21 U.S.C. 350b(a)(2) (section 413 of the Federal Food, Drug, and Cosmetic Act (the Act)) and 21 CFR 190.6. Yo ...
CHILD RESISTANT PACKAGING REGULATION
CHILD RESISTANT PACKAGING REGULATION

... oral drugs packed in unit dose packs: any child of 11.4 kg* who opens or gains access to the number of individual units which constitute the “harmful dose”, or a child who opens or gains access to more than 8 individual units  The CFR title 16, part 1700 discusses packaging test procedures extensiv ...
Swine: Baytril® 100 is indicated for the treatment and control of
Swine: Baytril® 100 is indicated for the treatment and control of

... were evaluated. BRD and mortality were significantly reduced in enrofloxacin-treated calves. No adverse reactions were reported in treated animals. The effectiveness of Baytril® 100 for the control of respiratory disease in cattle at high risk of developing BRD was evaluated in a six-location study ...
Chapter 2 - Test Bank Mango
Chapter 2 - Test Bank Mango

... D. Duration of action of the drug is too long ____ 10. Drugs that are receptor agonists may demonstrate what property? A. Irreversible binding to the drug receptor site B. Up-regulation with chronic use C. Desensitization or down-regulation with continuous use D. Inverse relationship between drug co ...
a drug by any other name ?: paradoxes in dietary supplement risk
a drug by any other name ?: paradoxes in dietary supplement risk

... IS. The FDCA defines a "drug" as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man" and "articles (other than food) intended to affect the structure or any function of the body of man." 21 U.S.C. § 321(g)(1)(B)-(C). The definitional provisions ...
Special Considerations for Unused Drugs Subject to Restricted
Special Considerations for Unused Drugs Subject to Restricted

Egg residue considerations during the treatment of backyard poultry
Egg residue considerations during the treatment of backyard poultry

WHAT ARE THE ISSUES IN DOSE FINDING?
WHAT ARE THE ISSUES IN DOSE FINDING?

... the selection in dose range for the early studies  Although not always attainable in early studies, a goal should be to try and define the Maximum Tolerated Dose (MTD), the Maximum Effective Dose (MaxED), and the Minimum Effective Dose (MinED) ...
drug-food interactions and role of pharmacist
drug-food interactions and role of pharmacist

YAZ® and YASMIN - James A. Simon, MD
YAZ® and YASMIN - James A. Simon, MD

< 1 ... 74 75 76 77 78 79 80 81 82 ... 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