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Generic and Branded Levothyroxine Preparations Are Not
Generic and Branded Levothyroxine Preparations Are Not

... Generic substitution of levothyroxine (L-T4) products determined to be bioequivalent by the Food and Drug Administration (FDA) is allowed in the United States. Bioequivalence is determined based on short-term pharmacokinetic studies of serum T4 levels—and no assessment of chronic TSH responses—in he ...
Vivitrol® (naltrexone) (Intramuscular)
Vivitrol® (naltrexone) (Intramuscular)

... √ Post-service edit: ...
AS DRUG PRICE SCRUTINY RISES, PRESSURE BUILDS TO
AS DRUG PRICE SCRUTINY RISES, PRESSURE BUILDS TO

Swiss_Medica_-_Inves.. - Arthritis Pain Relief | Joint Pain Relief
Swiss_Medica_-_Inves.. - Arthritis Pain Relief | Joint Pain Relief

... actual results to differ materially from those expressed or implied in such statements. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. The estimates and statements contained in ...
Melanotan II - Rebound Health
Melanotan II - Rebound Health

... A number of products are sold online and in gyms and beauty salons as "melanotan" or "melanotan-1" which purport to have the same chemical make up as afamelanotide, of which the visual effect resulting from usage has been noted in an article by Wired.com as being "eerily similar to results obtained ...
compartmental vs. non-compartmental pharmacokinetic
compartmental vs. non-compartmental pharmacokinetic

... AUC is calculated by numeric (non-compartmental) method Absorption rate : Cmax and tmax are determined by visual inspection of the experimental plasma data ...
Clinical Trials Billing Compliance from A to Z
Clinical Trials Billing Compliance from A to Z

... Coverage may vary state to state, but services provide must be medically necessary. ...
ISMP Medication Safety Alert - Institute For Safe Medication Practices
ISMP Medication Safety Alert - Institute For Safe Medication Practices

... part vaccine packaged in cartons bag. Affix an auxiliary label to the containing vials of liquid DTaP-IPV carton to remind staff to use both and vials of lyophilized Haemophilus vials. To confirm administration of influenzae. Nurses administering the both components, staff should two-part vaccine fa ...
In-Process Revision:  LABELING
In-Process Revision: LABELING

... The label of an official drug product or nutritional or dietary supplement product shall bear an expiration date. All products shall display the expiration date so that it can be read by an ordinary individual under customary conditions of purchase and use. The expiration date shall be prominently d ...
เภสัชจลนศาสตร์
เภสัชจลนศาสตร์

... – Gene directs cellular functions through its products, protein. – Almost all enzymes are proteins so they have been directed by gene as well. – Drug-metabolizing enzymes:  Isoniazid: ...
click - PHILSPEN Main Page
click - PHILSPEN Main Page

Enhancing Solubility And Dissolution Rate of A Poorly
Enhancing Solubility And Dissolution Rate of A Poorly

... and better bioavailability than conventional tablets.6,7 Paliperidone/ziprasidone is a newer atypical anti-psycotic drug used in the treatment of schizophrenia, which is an ongoing mental disease. Frequent relapses occur in about 55% of schizophrenia patients8, mostly because of medication non-compl ...
TURKU – FINLAND and OSAKA - JAPAN Press release on February
TURKU – FINLAND and OSAKA - JAPAN Press release on February

... and is currently in phase II in the UK. The trial FPCLI001 (see www.clinicaltrials.gov) recruits today for the second part of the study and will use the selected optimal tolerated dose to treat patients who suffer from vascular leakage - Acute Lung Injury (ALI) and its more severe form Acute Respira ...
Psychotropic drug interactions
Psychotropic drug interactions

... no significant effect. There are numerous known interactions involving psychotropic drugs. Many interactions have minor clinical significance; however, there are many potentially hazardous interactions that should always be considered. The significance of a drug interaction can also vary between ind ...
I. Definitions A. Covered Recipients 1. Physicians Any physician
I. Definitions A. Covered Recipients 1. Physicians Any physician

... In the proposed rule, CMS stated that the exclusion for educational materials that directly benefit patients or are intended for patient use is limited to “materials” and does not include services or other items. PhRMA requested clarification from CMS as to whether and how educational materials inte ...
Discussion Paper renal immaturity in neonates
Discussion Paper renal immaturity in neonates

... dependent on the maturational status. PK/PD studies may therefore be needed in the neonate. Any deviation from these principles should be discussed and justified. Extrapolation may be justified for PK studies for example when the drug is expected to act on a micro-organism rather than the host. Howe ...
Human Research Seminar Series  How to Maintain Research Data Institutional
Human Research Seminar Series How to Maintain Research Data Institutional

... “There is no documentation of the name or initials of the person making entries in the records.” “Source data for various assessments could not be located.” “There is no record of who administered the study drug…Without a record of who administered the study drug, you cannot assure that these inject ...
A review of drug isomerism and its significance
A review of drug isomerism and its significance

... of drug so body is exposed to the lesser metabolic, renal and hepatic load of drug, there is easier therapeutic drug monitoring of the active pure active enantiomers. A  number of drugs are marketed now as single enantiomer like Levosalbutamol, Escitalopram, Naproxen, etc. Many antibiotics have only ...
Phenytoin
Phenytoin

... electrolytes • Drugs that need to be given on an empty stomach • Drugs which are given in liquid form particularly when multiple drugs or high volumes are given this way • Drugs with a narrow therapeutic index ...
The AL-1 Story
The AL-1 Story

... Discovery that d4T would treat HIV/AIDS Dr. Tai-Shun Lin (Yale) and Dr. William Prusoff (Yale) first discovered d4T's capability to treat HIV/AIDS. Yale University holds the key use patent. The patent number in the USA is 4,978,655 (Patent #4,978,655). The fourth antiretroviral drug on the market, i ...
The legality and ethics of self-prescribing
The legality and ethics of self-prescribing

... of newly diagnosed gliobastoma multiforme on March 15, 2005. Temozolomide is also currently under standard review by the FDA for the treatment of metastatic melanoma. Temozolomide has an orphan drug designation for the treatment of malignant gliomas and advanced metastatic melanoma. There are 4 stre ...
LMPS Research Poster-Template
LMPS Research Poster-Template

... interpretation and comments about the trial can be stored.  The program is comprised of three files: A program (.prc) file (51KB) and two database (.pdb) files (total size ~40KB, but dependent on amount of data entered).  A standalone PalmOS-based software application was developed using ...
LMPS Research Poster-Template
LMPS Research Poster-Template

...  The software allows the user to add “notes” to a trial where their own interpretation and comments about the trial can be stored.  The program is comprised of three files: A program (.prc) file (51KB) and two database (.pdb) files (total size ~40KB, but dependent on amount of data entered). ...
August—December 2006 - Intellectual Property Owners Association
August—December 2006 - Intellectual Property Owners Association

PIO Nas - Badan Pengawas Obat dan Makanan
PIO Nas - Badan Pengawas Obat dan Makanan

... (2) Nasea OD Tablet should only be used to treat severe nausea and vomiting associated with carcinostatics (such as cisplastin). (3) Nasea OD Tablet should be used mainly for preventing nausea and vomiting when carcinostatics (such as cisplastin) that causes these reactions are administered. Nasea I ...
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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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