Biopharmaceutic classification system (BCS) is a substantial part of drug designing and generic product development and has been accepted as a technique to renounce in-vivo pharmacokinetic evaluation (biowaiver). It appeared to be worthwhile and time-saving by means of in-vitro studies in the presence of biorelevant physiological mediums that mimic not only the predictable solubility but also permeability of the multisource product. Such methodology is now applied as a regulatory stamp to support new and generic product approvals based on other than in-vivo equivalence testing. This article outlines the foundation of BCS, its implementation in granting biowaiver, adequacy of in-vitro bioequivalence studies, principles and requirements of BCS biowaiver by four regulatory agencies such as; Food and Drug Authority (FDA), World Health Organization (WHO), European medicine agency (EMA) and International Conference on Harmonization (ICH), potential effect of excipients on solubility and permeability of drug molecules and supplementary data provided by FDA regarding biowaiver approvals. Furthermore, supportive data provided by the International Pharmaceutical Federation (FIP) has also been given for biowaiver sanction of certain drug products. It has been concluded, that although biowaiver is a profitable methodology for generic and new drug product approval, the variance in the standards of governing bodies demands more critical assessment to establish some unified principles to be followed globally.
Urinary tract infection (UTI) is caused by bacteria growing in urine and affect kidneys, bladder, ureters, and urethra. Women with diabetes are at high risk of developing UTI. This is a case of a 60-year-old postmenopausal woman with uncontrolled type-I diabetes mellitus and hypertension, who presented with an acute onset of dysuria, burning micturition, and increased frequency. This case highlights the shortfall in the preliminary management plan of performing imperative clinical laboratory investigations including urine detailed report (DR), urine culture and sensitivity(C/S), and plasma glucose testing to initiate antimicrobial treatment. UTI requires to be treated precisely in diabetic patients with the help of a comprehensive diagnosis for signs of dysuria, frequent urination, and pelvic pain. The treatment of UTIs should always begin with culture and sensitivity analysis while the patient is symptomatic, to initiate antimicrobial treatment. Comorbidities should be managed appropriately during treatment to achieve desired therapeutic outcomes.
The applications of nanotechnology significantly benefit clinical practices in cancer diagnosis, management and treatment. This article reveals the application of nanotechnology in cancer treatment by using the different strategies for example use of nanoparticles like liposomes, dendrimers, nanoshells, carbon nanotubes, superpara-magnetic, silver/gold nanoparticles and nucleic acid based nanoparticles as well as the nanotechnology for a combination of therapeutic strategies. The advantages and challenges of these particles are also discussed. The use of different green synthesized based gold and silver nanoparticles are important for the apoptosis of different types of cancerous cells. Both size and shapes of these particles are important from the biological point of view and from the material characteristics. In present review we have also highlighted the role of some advanced nano-technologies and bio-therapeutics for diagnose and treatment of this lethal disease.
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