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Acceleration of new medicines–CMC lessons learned from …

WEBAn introduction was provided by Kin Tang, Thomas Oliver, Jessica Ursin, and Reza Oliyai. The team presented and discussed (a) accelerated regulatory pathways, …

Actived: 9 days ago

URL: https://aapsopen.springeropen.com/articles/10.1186/s41120-023-00089-2

Best practices for the development and fit-for-purpose validation …

WEBThis conference report summarized a full-day workshop, “best practices for the development and fit-for-purpose validation of biomarker methods,” which was held …

Category:  Health Go Health

Structured content and data management—enhancing

WEBThe decision to pursue an expedited review pathway with a particular health authority is typically associated with success in early-stage clinical development trials …

Category:  Health Go Health

Drug manufacturing and access to medicines: the West

WEBIt is the right of all humans to have access to safe, quality and effective medicines. This article seeks to expound on the problems of drug manufacturing and …

Category:  Medicine Go Health

Safety and pharmacokinetics of a highly bioavailable resveratrol

WEBResveratrol or 3,5,4′-stilbenotriol (Fig. 1) is a secondary metabolite present in around 70 plant species, which was isolated for the first time in 1940 from white …

Category:  Health Go Health

Comparison of rates of nausea side effects for

WEBThe term “side effect” typically refers to an unintended response to a medication that is related to the pharmacological properties of that particular medicine …

Category:  Medicine Go Health

ANVISA: an introduction to a new regulatory agency with many …

WEBBrazil, the largest country in South America, has become the second largest pharmaceutical market in the emerging world. The Brazillian Health Surveillance …

Category:  Health Go Health

Developing key performance indicators to measure the

WEBRegulatory convergence and cooperation among the authorities in the field of medical products (medicines and medical devices) are essential to deliver safe and …

Category:  Medical,  Medicine Go Health

A review of in vivo and in vitro aspects of alcohol-induced dose

WEBThis review provides a comprehensive list of in vivo and in vitro studies that have investigated alcohol induced dose dumping (AIDD) in modified release dosage …

Category:  Health Go Health

Substandard and falsified medicine screening technologies

WEBThe proliferation of substandard and falsified (SF) medicines is a significant global concern, particularly in low- and middle- income countries (LMICs) where supply …

Category:  Medicine Go Health

Scientific and regulatory approaches to confirm quality

WEBThe rapidly growing medical expense going with aging population in Japan requires the use of generic products derived from off-patent active pharmaceutical …

Category:  Medical Go Health

Glycopeptide antibiotic drug stability in aqueous solution

WEBGlycopeptide antimicrobials are a class of naturally occurring or semi-synthetic glycosylated products that have shown antibacterial activity against gram …

Category:  Health Go Health

Utilization of risk-based predictive stability within regulatory

WEBRisk-Based Predictive Stability (RBPS) tools, such as the Accelerated Stability Assessment Program (ASAP) and other models, are used routinely within …

Category:  Health Go Health

Stability considerations for drug-device combination products-21 …

WEBCombination products are therapeutic and diagnostic products that include two or more of the following: drug, biologic, and device. These products are needed for …

Category:  Health Go Health

ANVISA: an introduction to a new regulatory agency with

WEBThe Brazillian Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria - ANVISA) was created in 1999 with the primary goal to protect and promote …

Category:  Health Go Health

Designing an ideal alcohol-based hand sanitizer: in vitro …

WEBHand hygiene utilizes handwashing or hand sanitizers to render the hands free of pathogens and has become more emphasized in the COVID-19 pandemic …

Category:  Health Go Health

Bioequivalence clinical trial simulation: a case study of apalutamide

WEBPatients who have difficulty swallowing apalutamide tablets may benefit from administration in a food vehicle that is easier to swallow. In a previous single-dose study …

Category:  Food Go Health