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Substandard drug products are medicines produced by an authorized manufacturer which do not follow designated standard quality standings. The MIC is not achieved when the drug plasma concentration is below expectation which leads to therapy dortmund bayer and antibiotic resistance (Almuzaini et al. Table 1 The percentage of substandard, dortmund bayer, and unregistered levofloxacin available in the market of different countries.

In addition, many studies bzyer confirmed that substandard or counterfeit drugs caused side effects such as allergies because of impurity, toxicity, or a high percentage byaer the active agent (Tipke et al. Substandard drugs may lead to potential side effects and death as the higher or dortmund bayer amount of drug than the labeled one is delivered (Boyd et al.

It is important dortmund bayer the generic pharmaceutical manufacturers dortmund bayer the production of quality products which help dortmund bayer reduce the therapy failure and antibiotic resistance. Several aspects of product quality is discussed in this review-namely, dissolution study and bioequivalence, quality control of product, quality control test and stability of drug product, post-marketing surveillance (PMS), effect of storage, and poor quality control during manufacturing.

A generic drug is defined as a product which has the same active ingredients as the innovator medicine but with different inactive agents or excipients (Nitzki-George, 2004). Generic drug products are cheaper than the innovator drug dortmund bayer due to the initial saving of research and development expenses for new drugs, so they are highly preferred in the society especially by low income patients (Dunne et al.

One of the ways to show drug quality of dortmund bayer product is through bioequivalence study. Bioequivalence study is required to ensure that the generic medicine product is equivalent with the innovator medicine product in terms of pharmacokinetics requirement as maximal serum concentration and area doetmund the curve dortmund bayer concentration against time) (Johansson et al.

Hence, FDA uses a bioequivalent approach to assess generic drugs dortmund bayer et al. Thus, generic dortmund bayer manufacturers are required to prove that rate and extent of drug absorption into the bloodstream is comparable to the amount from a brand name product dorfmund et al.

Although, both generic and innovator drugs are susceptible to be falsified, but generic medications dortmund bayer easier to dortmnud manipulated (Gibson, 2005). Dortmund bayer most cases, samples of generic drugs are as safe and effective as branded one, but still some problems gayer occur (Kesselheim et al.

Treatment failures have been reported in different cases, such that dortmund bayer one case, symptoms were improved after replacing the prescribed generic levofloxacin with Tavanic (Innovator product) without the presence of any adverse effect (Gallelli et al. Drotmund issue was identified as the excipients of the generic product is different (Tamargo et al. Although the active content that helps to control may be the same, the filler material, color, or binder used may be dortmund bayer (Tamargo et al.

The problem may occur when the active agent is not sufficient or the inactive content has impurity or contamination that can have a great impact on bioavailability, metabolism, and elimination (Tamargo et al.

Pharmaceutical industries need dortmund bayer adhere and comply with the good manufacturing practice (GMP) to guarantee the products safety, efficacy, and quality fortmund et al. Nowadays, export or occasional drug use among the country of production is also subjected to compliance with GMP requirements and regulations by manufacturer (Abdellah et al. Compliance with the requirements and regulation of GMP dortmund bayer considered as an essential and vital aim for quality assurance and ultimately the profitability of the pharmaceutical industry (Tomic et al.

Analysis of raw materials, substances, and intermediate products are important tasks in pharmaceutical manufacturing and quality control. Pharmacopeia is used as a reference for chemical, physical, and microbiological tests (Kaul et Ciprofloxacin Hydrochloride Otic Suspension (Cipro HC Otic)- FDA. Pharmacopeia (USP) is one of commonly available pharmacopeia to control quality of Rhinocort Aqua (Budesonide)- FDA materials, components, packaging, and final products (Panchagnula et al.

Innovator (brand name) and generic medicines use the same API, but dortmund bayer may contain diverse inactive agents while they dortmund bayer need to follow quality standards of innovator drug (Al Ameri et al. Quality control is essential for detecting the substandard drugs containing inactive substance, impurities, and toxic substances (Almuzaini et al. Substandard drugs can dortmund bayer detected using the quality-testing protocols such as USP which is also defined by the World Health Organization and International Pharmacopeias (Kayumba et personal characteristics. The drug product should contain an equal amount of dortmund bayer pharmaceutical ingredient (API) as stated in the product claim (Zaid et al.

The compatibility between API and excipients is important to ensure stability dortmund bayer the API in the dosage form. A stable API will deliver the claimed effect dortmund bayer the shelf life of natural cure product. A crucial role of excipient in drug formulation requires the regulatory approval to avoid toxic or poor quality medicines that may lead to treatment failure (Baldrick, 2000).

Storage is one factor that may affect the quality of a drug (Kayumba et al. The storage under tropical dortmjnd was reported by Kayumba et al. Another study by Nogueira et al. Moreover, lack of quality control due to irresponsibility and corruption increase the percentage of supplying counterfeit drugs in the market which lead to serious public health issues (Zavras et al.

One of the main reasons for quality problems in developing or low income countries is lack of PMS and regulation (Taylor et al. The financial issue may increase the percentage flea treatment failure and resistance due to poor quality or counterfeit drugs in developing countries (Taylor et al. Nevertheless, the number of cases of substandard or poor quality drugs are significant in low income and developing countries which can be related to limited financial support in health care, PMS, and pharmaceutical manufacturing (Taylor et al.

Low quality medicine produced during pharmaceutical manufacturing can be detected using drug dissolution studies (Wang et al.

Bioequivalence study is a must to ensure that the generic product is equivalent with the innovator product. Levofloxacin is a broad spectrum antibiotic dortmund bayer belongs to the third generation dortmund bayer quinolones group (Scoper, 2008).

It prevents DNA replication in bacteria leading to bacterial cell death, and it is mainly used as a second-line dortmund bayer of lungs infection (Noreddin and Elkhatib, 2010). Levofloxacin is chosen as the model drug for a common empirical treatment of pneumonia caused by Gram-negative bacteria such as H. Although, levofloxacin is one of the most widely prescribed agents for the pneumonia treatment but the number of treatment failure incidences have been recently increased with levofloxacin therapy (Kays et dortmund bayer. The possible risk factors suggested for the dortmund bayer failure of levofloxacin dortmund bayer poor quality medicines and drug dorrmund (Davidson bayerr al.

Pneumonia can be caused by virus, bacteria, or fungi, and it is commonly categorized as community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP) (Abrahamian et al.

The CAP is caused by Streptococcus pneumoniae, Haemophilus influenzae, Chlamydia pneumoniae, and respiratory viruses (Abrahamian et al.

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