• 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
Formulation and In Vitro Evaluation of Minoxidil Topical Gel
Formulation and In Vitro Evaluation of Minoxidil Topical Gel

... Tt are the percent drug released at each time point for the reference and the test, respectively. The similarity factors of all the formulations were found out in comparison to Tugain gel in order to get highest similarity. In addition, comparisons were also made between the prepared formulations. A ...
A New Therapeutic Applications for Drug Repositioning
A New Therapeutic Applications for Drug Repositioning

... replace. According to experts, Efficacy end points have the opportunity to meet with the same success as the original drug. Also, they are not without risks of original drugs. FDA's 505 (b) (2) approval to change the route and marketing allows companies to offer improved safety and efficacy of drugs ...
Enrolled - Medical Marijuana ProCon.org
Enrolled - Medical Marijuana ProCon.org

... 20. "Immediate precursor" means a substance which the Director has found to be and by regulation designates as being the principal compound commonly used or produced primarily for use, and which is an immediate chemical intermediary used, or likely to be used, in the manufacture of a controlled dan ...
ALFENTANIL 500 MICROGRAMS / ML SOLUTION FOR INJECTION
ALFENTANIL 500 MICROGRAMS / ML SOLUTION FOR INJECTION

... Injection are well defined and controlled. The specifications and batch analytical results indicate consistency from batch to batch. There are no outstanding quality issues that would have a negative impact on the benefit/risk balance. PRECLINICAL No new preclinical data were submitted and none are ...
Bioburden Control of Non-sterile Drug Substances and Products
Bioburden Control of Non-sterile Drug Substances and Products

... How should drug substance and drug product  should drug substance and drug product manufacturers react to the publication of this  chapter?  • I would hope that they should adopt a more risk‐ based approach to bioburden control in non‐sterile  drug development and manufacturing based on an  understa ...
AusPAR: Doxycycline monohydrate
AusPAR: Doxycycline monohydrate

Product Information: Dolutegravir (as sodium)
Product Information: Dolutegravir (as sodium)

Imodium Liquid, 2 mg/ 15 ml oral solution PL 15513/0182
Imodium Liquid, 2 mg/ 15 ml oral solution PL 15513/0182

... OVERALL CLINICAL CONCLUSION Pharmacokinetics The pharmacokinetic parameters obtained in this bioequivalence study are comparable for both formulations. Efficacy and safety No new efficacy or safety data are presented. The applicant has referred to the well established efficacy and safety of loperami ...
Pharmaceutical Applications of Ispaghula Husk
Pharmaceutical Applications of Ispaghula Husk

... Isabgol (plantago ovata forskal) has attracted Carbohydrate chemists in last decade, as the hydrogel produced by it is rigid, difficult to brake, to dissolve. Ironically solubility, flexibility is very important criteria for materials to be used in pharmacy. To meet these criteria chemical modificat ...
Enzymes
Enzymes

Product Information - Therapeutic Goods Administration
Product Information - Therapeutic Goods Administration

... dose to minimise occurrence of withdrawal symptoms. Patients should be advised to consult with their physician before either increasing the dose or abruptly discontinuing the medication. Rebound phenomena have been described in the context of benzodiazepine use. Rebound insomnia, mood changes, anxie ...
Modern Methods in Drug Discovery
Modern Methods in Drug Discovery

UNITED STATES SECURITIES AND EXCHANGE COMMISSION
UNITED STATES SECURITIES AND EXCHANGE COMMISSION

... Initial clinical results from the ongoing Phase 1/2 study of ALN-GO1 at the 17th Congress of the International Pediatric Nephrology Association (IPNA), being held September 20 – 24, 2016 in Iguaçu, Brazil, in an oral presentation on Saturday, September 24, at 3:25 pm Brasília Time (2:25 pm ET). Init ...
Investigator Agreement Page
Investigator Agreement Page

... or bilateral oophorectomy) or they are postmenopausal. Females must not be breastfeeding. ...
one  that I'm not aware
one that I'm not aware

... OTC products ...
PATTON BOGGS, L.L. P. 1660
PATTON BOGGS, L.L. P. 1660

... The term “controlled substance” means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of this subchapter. These five schedules of controlled substances are a part of 21 U.s.c. S812. In the United Statesr there are three criteria which must be co ...
Clinical trials in children
Clinical trials in children

Product
Product

... be contraindicated in breast cancer and treatment regimens. Flaxseed and Flaxseed oil – some evidence for benefit Evening primrose oil- not consistent evidence for benefit Chasteberry- helps in PMS but ? for menopause Dong quai- no observed benefit in one good study Yam- is a scam Topical progestero ...


... Invasive fungal infections have transitioned from a rare curiosity to an everyday problem for the practising physician. Invasive candidiasis is the third to fourth most common bloodstream infection in surveys in the United States. Similar trends have been reported in several regions throughout the w ...
Approaches using molecular imaging... PET in Clinical microdose
Approaches using molecular imaging... PET in Clinical microdose

... considerable drawback, however, stems from the fact that relatively few drug molecules contain fluorine in their native structure. Consequently, despite the rather short half-life of 11C (20.4 min), the majority of PET microdose studies have relied on 11C-labeled drug molecules. A commonly employed m ...
Parikh, D., et al. (2012)
Parikh, D., et al. (2012)

... powder delivery to the lung, it can be difficult to achieve due to complexities of material chemistry and possible interactions between the active components. This can be very complicated when dual and triple therapy options are considered. With powder blends, the co-deposition of actives (ics and L ...
Role of US Military Research Programs in the Development of US
Role of US Military Research Programs in the Development of US

... the manufacturing of this drug until scientists in the United States successfully manufactured it in 1941. Concerns about skin yellowing and Japanese propaganda suggesting that atabrine caused impotence created noncompliance after it became available for service members. Dosing studies were undertak ...
Atorvastatin (Lipitor®) / Amlodipine/atorvastatin (Caduet®) Policy
Atorvastatin (Lipitor®) / Amlodipine/atorvastatin (Caduet®) Policy

... This Pharmacy Policy document describes the status of pharmaceutical information and/or technology at the time the document was developed. Since that time, new information relating to drug efficacy, interactions, contraindications, dosage, administration routes, safety or FDA approval may have chang ...
Untitled
Untitled

... and nurses from the institutions under the HA. The Working Group was appointed to review the existing drug administration systems in public hospitals and a set of Recommended Practices was then drawn up for the improvement of the overall standard and quality of service. The Pocket Version is an abri ...
Non-Clinical Investigation of the Dependence Potential of Medicinal
Non-Clinical Investigation of the Dependence Potential of Medicinal

< 1 ... 40 41 42 43 44 45 46 47 48 ... 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