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Revised: September 2016 AN: 01143/2015 SUMMARY OF
Revised: September 2016 AN: 01143/2015 SUMMARY OF

Checklist for Determining if Activity is Human Research
Checklist for Determining if Activity is Human Research



... an appropriate measure, since it would contribute to the safe use of drugs, and would increase the effectiveness of actions of pharmacovigilance. To optimize results in pharmacovigilance the contribution of health professionals and of the patients themselves – who are considered to be the priority t ...
FSQA Exam #3
FSQA Exam #3

... The regulatory agency responsible for determining tissue tolerance for most animal health products. a. EPA – Environmental Protection Agency b. FSIS – Food Safety and Inspection Service c. FDA – Food and Drug Administration ...
Drug Action Measurement
Drug Action Measurement

... …… Potency corresponds to the strength of a drug, while Efficacy corresponds to the effectiveness of a drug. …… e.g., if 1 mg of drug A relieves pain as effectively as 10 mg of drug B, drug A is twice as potent as drug B …… the diuretic furosemide eliminates much more salt and water through urine th ...
Durogesic Article-30 referral
Durogesic Article-30 referral

... indicated in section 4.1 of the proposed harmonised SmPC, and also present in the majority of SmPCs. The proposed wording has been developed to align the populations evaluated in clinical studies and to maintain alignment between the indications for both adult and paediatric patients. Section 4.2 – ...
Neuroleptic malignant syndrome
Neuroleptic malignant syndrome

...  Bromocriptine (may worsen serotonin syndrome)  Dopamine (rqs conversion to epinephrine) ...
View PDF - Auspherix
View PDF - Auspherix

... be in the body without actively multiplying and then pop out and start growing again once antibiotics have cleared from the body. The XF drugs have been shown to be active against bacteria at any growth phase whether they are actively growing or in fact if they are not growing at all,” the executive ...
New Drugs from Old
New Drugs from Old

... • Typical for pharmaceutical products to be covered by 20 - 40 different patents, including the manufacturing process, formulation, salts & isomers etc. • Earlier the drug can be brought to market, the quicker it can start to recoup R&D (research and development) costs and return a profit (c) S.Pegl ...
Therefore, need to be used during pregnancy
Therefore, need to be used during pregnancy

... me to get this drug. For your protection, you shouldn’t seek advice from your doctor how to safely take this medicine in larger or smaller amounts or for longer than 5 years: IV: 1 mg slow IV every 2 months to monitor renal function. Talk with your eye doctor. So I used phentermine for three to five ...
schering-plough gmp consent decree puts drug
schering-plough gmp consent decree puts drug

... to support it, but in my opinion, these companies appear to be making a calculated decision.” Pharmaceutical companies are quickly learning that a sanguine attitude about inspection reports and warning letters is a costly mistake. Under the new enforcement environment, firms in violation are likely ...
INTERVIEW: MIR IMRAN, RANI THERAPEUTICS
INTERVIEW: MIR IMRAN, RANI THERAPEUTICS

... bit, but at present it is of a size that most people can take it relatively easily. ...
Psychopharmacology
Psychopharmacology

... Comparatively little known about dependence  Withdrawal often accompanied by dysphoria ...
E-Cronicon
E-Cronicon

... factors [9], and monoclonal-antibodies [5]. In addition, this newly advanced molecular biology technology resulted in significant new bio products not only in medicine but in a wide broad applications such as but not limited to agriculture, food processing, nutritional health , bio fuels, biochemica ...
Deprescribing in older adults - Ohio Medical Directors Association
Deprescribing in older adults - Ohio Medical Directors Association

Prescriptions Drugs 101
Prescriptions Drugs 101

... solubility of a drug affects the way it permeates and binds to tissue. ◦  Water-soluble drugs can move through pores in tiny blood vessels called capillaries, but can’t move through cell membranes. They have an electrical charge. ◦  Fat-soluble drugs can cross pores, cell membranes, and the blood-br ...
11:30 AM Using Genetics for Drug Prescribing: Will it Happen?
11:30 AM Using Genetics for Drug Prescribing: Will it Happen?

PHARMACOLOGY SKILLS 2
PHARMACOLOGY SKILLS 2

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Title of PowerPoint 32 pt Arial

... Preface and Disclaimer “FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements a ...
the Contraceptive Use Policy - Duke IRB
the Contraceptive Use Policy - Duke IRB

... Category B. Reproduction studies have been performed in (kind(s) of animal(s)) at doses up to (x) times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to (name of drug). There are, however, no adequate and well-controlled studies in pregnant women. Becau ...
Felimazole 2.5 mg - Veterinary Medicines Directorate
Felimazole 2.5 mg - Veterinary Medicines Directorate

Benefit vs. Risk: How CDER Approves New Drugs
Benefit vs. Risk: How CDER Approves New Drugs

... Research has always applied the same standards to nonprescription drugs as it does to prescription ones whenever proposed over-the-counter (OTC) products meet the criteria for new drugs. An OTC drug product does not need specific approval before marketing so long as it meets its category’s standards ...
drug approval process for the treatment of alzheimer`s disease
drug approval process for the treatment of alzheimer`s disease

... take up to at least three years to find out if the treated group does better than the untreated one, and to confirm drug dosages which work without causing adverse side effects. If a drug successfully maintains its original promise right through to the end of the Phase 3 trial, it is submitted to th ...
News New Jersey State Board of Pharmacy October  2014
News New Jersey State Board of Pharmacy October 2014

... www.ismp.org/sc?id=337. The white paper supports mL as the standard unit of liquid measure used on prescription container labels for oral liquid medications. It also calls for dosing devices with numeric graduations, and for units that correspond to the container labeling to be easily and universall ...
ไม่มีชื่อเรื่องภาพนิ่ง
ไม่มีชื่อเรื่องภาพนิ่ง

... Problem Statement: Surveillance of drug product quality is currently conducted as part of Universal Health Coverage Program, namely “30-Baht Co-payment Scheme”. This is to ensure that pharmaceutical products marketed in Thailand meet standard specifications for identity, strength, quality, purity an ...
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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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