Pharmaceutical alternatives are Drug products in identical dosage forms that contain the same active ingredient(s), ie, the same salt or ester, are of the same dosage form, use the same route of administration, and are identical in strength or concentration (eg, chlordiazepoxide hydrochloride, 5-mg capsules). Pharmaceutically equivalent drug products are formulated to contain the same amount of active ingredient in the same dosage form and to meet the same or compendial or other applicable standards (ie, strength, quality, purity, and identity), but they may differ in characteristics such as shape, scoring configuration, release mechanisms, packaging, excipients (including colors, flavors, preservatives), expiration time, and, within …show more content…
The concept of therapeutic equivalence, as used to develop the List, applies only to drug products containing the same active ingredient(s) and does not encompass a comparison of different therapeutic agents used for the same condition (e.g., propoxyphene hydrochloride vs. pentazocine hydrochloride for the treatment of pain). Any drug product in the List repackaged and/or distributed by other than the application holder is considered to be therapeutically equivalent to the application holder's drug product even if the application holder's drug product is single source or coded as non-equivalent (e.g., BN). Also, distributors or repackagers of an 1 application holder's drug product are considered to have the same code as the application holder. Therapeutic equivalence determinations are not made for unapproved, off-label indications. FDA considers drug products to be …show more content…
A similar definition exists in the text “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book) published by the Food and Drug Administration (FDA) (3). While both the European Agency for the Evaluation of Medicinal Products (EMEA) and the FDA recognize the concept that pharmaceutical alternatives may be shown to be bioequivalent, the Orange Book (3) clearly states that only therapeutic equivalents that are pharmaceutical equivalents can be considered substitutable, whereas the EMEA states that either pharmaceutical equivalents or pharmaceutical alternatives may be considered as therapeutic equivalents provided that the excipients contained in the formulation do not impact on the safety and efficacy profile of the dosage form (2). Pharmaceutical equivalents are defined in the Orange Book (3) as drug products that contain the same active ingredient(s), are of the same dosage form, route of administration and are identical in strength or
Case: 791 F2d 189 Thompson Medical Co. Inc. v. Federal Trade Commission Facts: This case concerns a complaint brought by the Federal Trade Commission ("FTC" or "Commission") against petitioner Thompson Medical Company under Secs. The Commission ordered Thompson to refrain from making unsubstantiated claims that Aspercreme is effective and to disclose in the product 's labeling and advertising that it does not contain aspirin. Thompson challenges the FTC 's order as arbitrary and capricious, contrary to public policy, unsupported by substantial evidence, and discordant with applicable Commission precedent.
On addition, had to pay the ACCC’s costs. Primary stakeholders: o Health professionals and buyers who have been informing and guiding parents and children on responsible use of the medication would affected the most. The Specific pain case would have resulted in losing trustworthiness and honesty between the health professionals and the patients. The buyers in situation would have lost faith in the company and might prefer choosing another brand.
Pharmacologists and biotechnologists fusing genomics are presently spinning more towards a customized medicine to encourage the endorsement of new medications and in addition to propel the medication improvement process. "Pharmacogenomics inspects the acquired varieties in qualities that manage drug reaction and investigates the ways these varieties can be utilized to foresee whether a patient will have a decent reaction to a medication, a terrible reaction to a medication or no reaction by any
Right now in the United States of America, there is a monopoly that exists that involves epinephrine auto-injectors. EpiPen is the United States only supplier of these auto-injectors because other brands have suffered setbacks and failures, patent protection laws, and because there are currently no generic versions of EpiPen in the United States (Johnson). This monopoly was not a problem until Mylan bought Meda AB in 2007 (Paton). “Since Mylan bought the rights to EpiPen in 2007, it has raised the price on 15 separate occasions, bringing the current list price to $608 for a two-pack up from about $50 a pen in 2007” (Mole). This has been a price increase of more than 500%, and this shows that Mylan has been using the monopoly to its advantage.
Nowadays it seems like legal drugs are more expensive than illegal ones. This dilemma occurs because the pharmaceutical industry affects the economy significantly. Although the United States is a mixed market economy, there are instances where the economy seems like a free market economy. A free market economy allows companies to determine the prices of goods free from government intervention. The pharmaceutical industry, despite several regulations set by the food and drug administration, is a free market economy.
II. Places of deaths, most effective prescription drug comparison between states. Prescription drug abuse became an issue in every state in the U.S., However, there are some states that have less number of deaths than others for not legalizing the types of drugs that the others states legalize, and abusers can be arrested for using non-medical drugs. Since the medical marijuana movement began, 23 states and the District of Columbia, starting with California in 1996, have legalized medical cannabis.
One study by Arnold et al. (2010) directly compared the two drugs in question for this project and provided credible information to the development of an evidenced-based answer to the problem (Arnold et al., 2010). A second systematic review by Akl et al. (2014) researched the effects of the two drugs in question in the thromboprophylaxis treatment of patients (Akl et al.,
The only part that was irrelevant was the appearance of the drug. All but one drug looked like white powder. Even white medicines are dyes to look white (“Toxins in Vitamins and Medicine”). The appearance of the drug therefore does not help us identify what drug the Unknown drugs are. Our conclusion is irrefutable because Unknown A was the same as Excedrin in every category we tested and the same goes for Unknown B and bufferin.
Reflection on Medication Administration Description (Competency 3j) I have looked over my moral development regarding medicine administration and have noticed there is the need for improved and has been agreed with my mentor to write a piece of reflection to identify areas of concern Feelings One of the major concern is the pace of dispensing and the time spent used to open charts and allocate them is one of my weakness. Although I am learner I need to back up the pace of dispensing so that patient doesn 't feel my skills is dull or boring and waste of time. I Had developed that feeling of being extra careful to avoid drug error and that makes me feel slightly nervous more also being under the influence of supervision as well. Evaluation
Over the counter drugs are medicines sold directly to a consumer and do not require the prescription of a registered medical practioner. So they are also known as non prescription drugs. This is a serious and growing global health challenge. Some OTC medicines relieves aches, pain and itches. Some prevent or cure diseases like tooth decay and athletes foot.
Meta Description: Vitamin K is an essential nutrient that helps the blood clot and is not ordinarily used as a dietary supplement. Vitamin K is a group of compounds with the most important compounds being vitamin K1 and vitamin K2. Overview Vitamin K is a fat-soluble vitamin stored in very small amounts in the body that are often depleted during dietary intake. Because the body is unable to store vitamin K, it recycles itself several times for protein carboxylation, therefore decreasing the need as a daily requirement. Natural occurring forms of vitamin K are phylloquinone (vitamin K1) and menaquinones (vitamin K2) with vitamin K1 the main form of vitamin K available in the U.S.
In this essay, two communication attempts will be analysed and evaluated based on established communication models. I will first introduce you to the organisation I work with, Ego Pharmaceuticals, and also give you a brief breakdown of communication theory. Next, I will analyse two attempts at communication within the organisation. As a Demand Analyst at Ego Pharmaceuticals, my job primarily involves developing statistical models, and analysing data to determine trends and relationships. However a significant portion of my time now involves regular communication with a large number overseas staff in both Asia and the Middle East, relating to forecasting processes and models.
Threat of substitutes (low): This is one of the great advantages of the pharma industry. Because the demand for pharma products continues and the industry flourish. One of the main reasons for high competitiveness in the field is that it is an ongoing
PORTERS FIVE FORCES ANALYSIS - PHARMA INDUSTRY Using Porter's Five Forces we can analyse the scope of the pharmaceutical industry. It looks into five factors namely, competitive rivalry, threat of new entrants, threat of substitute products, bargaining power of suppliers and bargaining power of customers. " Competitive rivalry: The pharmaceutical industry is highly fragmented with almost 3,000 pharma companies and 10,500 manufacturing units. Due to increasing demand of high-quality drugs, low-to-moderate entry barrier to the new entrant, the presence of a number of large and small firm this market is highly competitive.
This can come in oral form, or they can come in an injectable form. These products