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syllebus
syllebus

... (i) (i) Prescriptions –Reading and understanding of prescription; Latin terms commonly used (Detailed study is not necessary), Modern methods of prescribing, adoption of metric system. Calculations involved in dispensing. (ii) (ii) Incompatibilities in Prescriptions –Study of various types of incomp ...
Pharmacokinetics is
Pharmacokinetics is

Increase of drug tolerance An alternative to acid dissociation
Increase of drug tolerance An alternative to acid dissociation

... •  Similar dose response for ADA detection in the absence of drug as the bridging assay without acid •  Percent recoveries are acceptable with 1 µg/mL of Drug but reduced to 35% at the 125 ng/mL of ADA with 10 µg/mL of Drug. •  The assay sensitivity was maintained for the 1 and 10 µg/mL of drug at a ...
1 - European Commission
1 - European Commission

... 1 January 2017, thus guaranteeing the parties which market medicinal products a transition period to adapt any marketing permits and registration documents. In order to avoid the withdrawal from the market of medicinal products which exceed the specified level of psychoactive substances, medicinal p ...
Antibiotic Safety Assessment
Antibiotic Safety Assessment

Slide 1
Slide 1

... Professions (BHPr), Health Resources and Services Administration (HRSA), Department of Health and Human Services (DHHS) under grant number UB4HP19199 “Geriatric Education Center of Pennsylvania”. ...
Pharmaceutical Regulatory and Compliance Congress and Best
Pharmaceutical Regulatory and Compliance Congress and Best

... Court for the District of Columbia. The states alleged that the firm monopolized the market for paclitaxel based anti-cancer drugs and unlawfully maintained that monopoly. The alleged unlawful conduct included: (i) fraudulent procurement of patents for the methods of use of Taxol; (ii) knowingly lis ...
Chemistry, Pharmacology, Toxicology, and Hepatic
Chemistry, Pharmacology, Toxicology, and Hepatic

... Unfortunately, until now, no experimental data on pharmacology and toxicology of this drug class have been published. Drugs of abuse such as cathinone, anorectics such as amfepramone, and antidepressants such as bupropion all incorporate an ␣-aminopropiophenone partial structure. They are known to e ...
Seattle Genetics, Inc. - corporate
Seattle Genetics, Inc. - corporate

... Bothell, WA – September 28, 2004 – Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that Bayer Pharmaceuticals Corporation (NYSE: BAY) has licensed Seattle Genetics’ proprietary antibody-drug conjugate (ADC) technology. The license provides Bayer with rights to utilize Seattle Genetics’ ADC tec ...
SYLLABUS OF SECOND PROFESSIONAL M.B.B.S.
SYLLABUS OF SECOND PROFESSIONAL M.B.B.S.

... Drug Interaction should be conducted Antibiotics: Frequency distribution of antibiotic prescribed in different clinical settings/units. Rational prescribing pattern of antibiotics. Parameters: provisional diagnosis, investigation, empirical therapy. Prescribing after culture and sensitivity. Vitamin ...
Dr. A. Ramkishan- CDSCO WHO TRS WPU
Dr. A. Ramkishan- CDSCO WHO TRS WPU

... What is GLP?  Good Laboratory Practice (GLP) deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded, reported & archived. GLP practices are intended to promote the quality and validity of test data (part 58 CFR 21). OR  GLP i ...
Cymbalta (Neuropathic Pain) - Forecast and Market Analysis to 2022 Brochure
Cymbalta (Neuropathic Pain) - Forecast and Market Analysis to 2022 Brochure

... include anticonvulsants, antidepressants, opioids and topical treatments. However, despite the availability of multiple pain medications only 50% of patients respond to any given drug and there are numerous the side effects associated particularly with systemically administered drugs, that reduce th ...
ICH, WHO AND SUPAC GUIDELINES  ICH GUIDELINES
ICH, WHO AND SUPAC GUIDELINES ICH GUIDELINES

... Step 2 of the ICH process is reached when the ICH Steering Committee agrees, based on the report of the EWG, that there is sufficient consensus on the technical issues for the draft guideline or recommendation to proceed to the next stage of regulatory consultation. The consensus text approved by th ...
Pharmacokinetics of Fenbendazole Suspension and Amoxicillin
Pharmacokinetics of Fenbendazole Suspension and Amoxicillin

Effects of Solubility and Dissolution Characteristics on Oral
Effects of Solubility and Dissolution Characteristics on Oral

two new third-generation antiepileptic drugs
two new third-generation antiepileptic drugs

Oral suspension
Oral suspension

...  This review briefly describes the efficacy of closantel plus albendazole liquid suspension against natural infection of gastrointestinal parasites in camels. Oral administration of closantel in a dose of 10 mg/kg plus albendazole in a dose of 5 mg/kg liquid suspension was studied in 75 camels nat ...
dry syrups - Pharmawiki.in
dry syrups - Pharmawiki.in

... • Common suspending agent in suspensions for reconstitution. • Produced by microbial fermentation, good batch-to-batch uniformity and few microbial problems. Required concentrations for rapid dispersion during reconstitution must be determined for each suspending agent. ...
Dry Syrups - Pharmawiki.in
Dry Syrups - Pharmawiki.in

ASHP Technical Assistance Bulletin on Compounding Nonsterile
ASHP Technical Assistance Bulletin on Compounding Nonsterile

... standards. In the event that a needed chemical is not available from an FDA-inspected facility, the pharmacist should, by next best preference, obtain a USP or NF product. If that is not available, the pharmacist should use professional judgment and may have to obtain the highest-grade chemical poss ...
(BE) Study Reports
(BE) Study Reports

... principles for the safety evaluation of drugs intended for the long-term treatment (chronic or repeated intermittent use for longer than 6 months) of non-life-threatening diseases. The safety evaluation during clinical drug development is expected to characterise and quantify the safety profile of a ...
drug interactions - Liverpool John Moores University
drug interactions - Liverpool John Moores University

... defend yourself? Pharmacokinetic Drug Interactions ...
The Development of Deuterium-Containing Drugs
The Development of Deuterium-Containing Drugs

... instances, modifying metabolic fate to substantially alter their overall therapeutic profile. In favourable cases, this modification has the potential to have a positive impact effect on safety, efficacy and/or tolerability. By starting from compounds with welldefined human pharmacological effects – ...
The Development of Deuterium-Containing Drugs
The Development of Deuterium-Containing Drugs

recent court decisions
recent court decisions

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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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