• 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
Client Information about ProHeart® 6 (moxidectin)
Client Information about ProHeart® 6 (moxidectin)

Lecture 5 hana
Lecture 5 hana

... viscous formulations (usually viscosity greater than 4 centipoise).  The smaller the ID, the potential greater difficulties encountered in needles clogging due to bridging of particles or insufficient force per unit area to eject viscous solutions.  The OD is important for the reason of the potent ...
3 Amphetamines in the Treatment of Attention
3 Amphetamines in the Treatment of Attention

... methylphenidate proved to be superior, but the single daily Adderall dose still provided a greater improvement in assessment scores over placebo. It should be noted that this study and the one prior to it were supported by a grant from Shire Laboratories, the maker of Adderall . While these newer ...
Topics
Topics

... and the disease in your target population  You do not have the time or money to simply recruit enough subjects in a simple way to answer you questions  And there are outcomes early enough in treatment to adapt to ...
drug master file: [18f]fdg
drug master file: [18f]fdg

... onto the analytical HPLC have demonstrated that the product is stable at room temperature for this period of time. The radiopharmaceuticals will be stored at room temperature prior to patient administration. Over this time under the conditions of storage there has been no chromatographic evidence of ...
Pharmacokinetics and doses of anti-TB drugs in children
Pharmacokinetics and doses of anti-TB drugs in children

... – Efficacy of Mfx in adults with TB shown in several studies • Cmax was higher than the mutant prevention concentration 90% (MPC90) of in vitro studies for MFX (1.2μg/mL) • Limited data on Mfx use in children with MDR-TB, but current recommended dose of 7.5-10mg/kg may be too low. Studies in younger ...
LEADS PHARMA
LEADS PHARMA

... the brand name of D-Acne / Teracne. Recently with the cooperation of its Asia Pacic Principals, Leads has introduced a variety of pain balms under the brand name of Dragon. Leads Market pain balms for all age groups including children. Few of the pain balms are innovative and are rst time introduc ...
A Resource and Data Quality Comparison : Absolute Bioavailability
A Resource and Data Quality Comparison : Absolute Bioavailability

Drugs - PHARMACEUTICAL REVIEW
Drugs - PHARMACEUTICAL REVIEW

... A) Renal: Non-volatile drugs and metabolites are excreted in the urine. The clearance of some drugs depends mainly on renal excretion (Little or no metabolism) e.g. Atenolol, Nadolol, Barbitone & Gallamine  Caution in Renal patients. Renal excretion is the result of glomerular ...
phera-plex - AnabolicMinds.com
phera-plex - AnabolicMinds.com

Principles of Pharmacology
Principles of Pharmacology

Dosage and route of administration The recommended
Dosage and route of administration The recommended

... Dosage and route of administration The recommended dose in adults is one 35 mg tablet once weekly by oral route. Method of administration The tablet should be taken on the same day each week. Food and drinks may interfere with the absorption of ACTONEL Once-a-Week 35 mg. Therefore, it is very import ...
Introduction to Bioequivalence Studies
Introduction to Bioequivalence Studies

... Sometimes it is not enough  Pharmaceutical equivalence by itself does not necessarily imply therapeutic equivalence  Therapeutic equivalence: – Pharmaceutically equivalent – Same safety and efficacy profiles after administration of same dose ...
METHODS OF STUDYING BIOAVAILABILITY AND BIOEQUIVALENCE  INTRODUCTION:
METHODS OF STUDYING BIOAVAILABILITY AND BIOEQUIVALENCE INTRODUCTION:

... parameters, eg, concentration of the active drug ingredient in the blood, cumulative urinary excretion rates, or pharmacological effects. – For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and ex ...
herbal nebulizer
herbal nebulizer

... Ayurveda by itself can tackle the needs of health care today, though some adaptation can make it more valuable in today’s world. Ayurveda has a three tier structure i.e. Tatwa (Principle), Shastra (Theory) and Vyavahara (Practice). Vyavahara is the development of new applications according to partic ...
Potential cardiovascular effects of dipeptidyl diabetes: current evidence and ongoing trials
Potential cardiovascular effects of dipeptidyl diabetes: current evidence and ongoing trials

... antidiabetic agents in clinical practice.19 Furthermore, the EMA recommends that clinical studies involving antidiabetic agents enrol a study population large enough to adequately detect safety signals, include patients at high risk for CV events, have a long-term duration of treatment (i.e. 18–24 m ...
introductory lecture in pharmacology
introductory lecture in pharmacology

... mucous membranes. These products contain an active drug that is incorporated into a vehicle (e.g., polyethylene glycol or petrolatum), which enables the drug to adhere to the tissue for a sufficient length of time to exert its effect. Lotions are liquid preparations often formulated as oil-in-water ...
mutism in autism
mutism in autism

... MFA is approved in juvenile arthritis • for chronic use • from 6 months of age. MFA is an NSAID (like Infant Motrin®), not a ‘psycho-active drug’. In 3 – 36 month old children • only 6 AEs were reported • over 50+ years of use. “no specific signal has been identified.” [EMA 2012] ...
From prescription-only to over-the
From prescription-only to over-the

... Most P-category medicines are used in the treatment of minor ailments or injuries, for health promotion, or in palliative care, although the list is beginning to include medicines that are used for acute and chronic conditions that do not fall into these categories and may also be extended to ‘lifes ...
IN THE GROWTH AND COMPOSmON
IN THE GROWTH AND COMPOSmON

... Lombardi and Bonnie Scouler, and discussions with Tim Brenahan, Stan Fmkelstein, M.D., Valerie Suslow and Stephen Wright, M.D. This paper is part of NBER's research programs in Industrial Organization and Productivity. Any opinions expressed are those of the authors and not those of the National Bur ...
Citeline Pharma R&D Annual Review 2015 Supplement: New Active
Citeline Pharma R&D Annual Review 2015 Supplement: New Active

... rapidly that the US FDA is now moving to rescind this status from follow-on drugs which were only granted it a little over a year ago. Alimentary/Metabolic was second biggest beneficiary of new drug launches, with thirteen. Type 2 diabetes again led the way here, with its six new molecules coming in ...
Metabolizing Enzymes and Transporter Proteins: How
Metabolizing Enzymes and Transporter Proteins: How

Prodrugs An inactive precursor of a drug, converted into its active
Prodrugs An inactive precursor of a drug, converted into its active

... Prodrugs An inactive precursor of a drug, converted into its active form in the body by normal metabolic processes. Prodrugs are used when drugs have unattractive physicochemical properties Prodrugs are bioreversible derivatives of drug molecules that undergo an enzymatic and/or chemical transformat ...
Preventing Anticoagulation Errors with Clinical Dashboards
Preventing Anticoagulation Errors with Clinical Dashboards

... • Oral factor Xa inihibitor • FDA approved for ortho prophylaxis – 10 mg daily ...
PersPectIves
PersPectIves

... glutathione S-transferase (GST) families — are commercially available, there are substantial gaps in the availability of purified or recombinant DMEs from other families. Several DTPs have been functionally expressed in recombinant cell-based assays, but these are generally not commercially availabl ...
< 1 ... 61 62 63 64 65 66 67 68 69 ... 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