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Specific ADRs
Specific ADRs

... administration shortly after rather than shortly before dialysis, so that even if the drug is dialyzable, very little is remaining to be removed by dialysis. ...
ANTI RHEUMATIC DRUG SAFETY DURING PREGNANCY
ANTI RHEUMATIC DRUG SAFETY DURING PREGNANCY

... B Animal studies have not demonstrated a fetal risk, but there are no adequate, well-controlled studies in pregnant women. Or Animal reproduction studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus. C Animal ...
ULLMAN, SHAPIRO &  ULLMAN. LLP
ULLMAN, SHAPIRO & ULLMAN. LLP

... weight with only mild to moderate gastrointestinal side-effects associated with the intake of Carallumafimbriata. These side-effects usually subsided within one week. Post-trial monitoring of total cholesterol, LDL, HDL, triglycerides, serum creatinine, BUN, total protein, serum albumin, total bilir ...
life-saving drugs for desperate patients at a fair price by
life-saving drugs for desperate patients at a fair price by

... 4-6 years in the 1960s. Currently it takes about 12 years to bring new drugs to market. Each new drug also requires up to $359 million in corporate investment. ...
Application of drugs based on release-active
Application of drugs based on release-active

... Reports in international press on adverse events associated with the drug use ...
presented testimony - Yale Law School
presented testimony - Yale Law School

... it was also careful not to entirely strike down the FDA’s authority to regulate off-label promotion. While the court decided that the government could not penalize speech itself, it suggested that the government might have prevailed if it argued that it was penalizing conduct – the conduct of selli ...
presentation
presentation

... t1/2 = Half-Life - the time taken for the plasma concentration to fall by half its original value ...
Anti HER2 mAbs
Anti HER2 mAbs

... (after an additional year of follow-up) ...
pharmazeutische zeitung
pharmazeutische zeitung

... group is still under patent11. As soon as this first drug substance is out of patent, other substances in the same group even if they are still patented - may be included in a reference price group along with the initial substance and derived generics. That also applies to completely new and still p ...
- San Diego State University
- San Diego State University

... pharmacy and see what medications are available to the general public and what they are indicated for. Pick up a few of them and read what the active ingredients are (the most potent ingredients are listed first). The more you learn and understand drug therapy, the more successful you will be in thi ...
Stratified medicine
Stratified medicine

... A well-known example in which these conditions have been fulfilled is provided by the anticancer drug trastuzumab, which has achieved blockbuster status although it is only efficacious for a population subset, in this case HER2/neu-positive cancers4. For patients with the appropriate genotype (clini ...
Ravimid laste jaoks
Ravimid laste jaoks

... Protection Certificate ...
HEMATOLOGy & ONCOLOGy
HEMATOLOGy & ONCOLOGy

... dose to avoid giving the large dose that a patient’s weight would indicate—perhaps to avoid potentially severe and harmful side effects. For those patients of lower socioeconomic status, doctors may be anticipating the patient’s attitude toward treatment, especially the side effects that come with a ...
PHARMACOLOGY : FIRST LONG EXAM Coverage: Principles of
PHARMACOLOGY : FIRST LONG EXAM Coverage: Principles of

... C. Assist patients in making informed choice for cost-effective drugs D. Encourage patients to debate with their physician on the efficacy of drugs 15. Also called “allopathic” medicine, this modality of treatment advocates therapy and remedies which produce effects differing from those of the disea ...
Bilberry 6000mg Product Detail Sheet
Bilberry 6000mg Product Detail Sheet

Juvenile Animal Toxicology Studies to Support Paediatric Drug
Juvenile Animal Toxicology Studies to Support Paediatric Drug

... medicines in children was lacking • Thus, substantial unlicensed and off-label use of adult medicines in paediatric population • Doctors prescribing medicines to children without knowing if they were effective, what dose was appropriate and what adverse reactions the child might suffer • Off-label u ...
Guidelines on the quality, safety, and efficacy of biotherapeutic
Guidelines on the quality, safety, and efficacy of biotherapeutic

... Developments in molecular genetics and nucleic acid chemistry have enabled genes encoding natural biologically active proteins to be identified, modified and transferred from one organism to another in order to obtain highly efficient synthesis of their products. This has led to the production of ne ...
Advanced Pharmaceutics
Advanced Pharmaceutics

... instrumental(?) tests 3. The efficacy of the treatment is not linked to the amount of drug given but to the choice of drug 4. This requires precise pharmacological criteria Mesotherapy requires 1. A sensible indication 2. A correct clinical assessment 3. Flawless technology 4. Proper technique 5. Su ...
Catabasis Pharmaceuticals Announces Positive Top
Catabasis Pharmaceuticals Announces Positive Top

The Art and Science of Traditional Medicine Part 2: Multidisciplinary
The Art and Science of Traditional Medicine Part 2: Multidisciplinary

... discovery can be structurally diversified by combining and Herbal genetic information is being accumulated with introducing plant metabolic pathways into other organisms, increasing speed, making the need for a common platform such as bacteria or yeast (6). The conventional practice in for integrate ...
1st Medicon Valley Inhalation Symposium
1st Medicon Valley Inhalation Symposium

... • Local exposure mostly agonists. • Hit‐and run principle.  Compounds that are rapidly cleared from lungs can still have  good effect. • Antagonist effects often require long‐term target inhibition. • Compounds need to have long lung‐retention. Needs to be  engineered into molecule from start. • Se ...
Lyrica (Neuropathic Pain) - Forecast and Market Analysis to 2022 Brochure
Lyrica (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 ...
Chapter Sixteen: Using Drugs Responsibly
Chapter Sixteen: Using Drugs Responsibly

... Far too many drugs are used by people to cope with symptoms and conditions that could be dealt with by safer, more effective means. Drug companies encourage the use of drugs for economic reasons. Doctors prescribe drugs excessively because patients expect it. ...
ISOA/ARF Drug Development Tutorial
ISOA/ARF Drug Development Tutorial

... industry experiences, but are by no means the only perspective on the highly complex and diverse field of drug discovery and development. For more comprehensive textbooks and reviews on this topic, please refer to our list of references below. Target Discovery—Overview Drug discovery and development ...
Drug Development Pipeline
Drug Development Pipeline

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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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