An Alternative Approach for Assessment of Rate of Absorption in Bioequivalence Studies

The partial area method was investigated for evaluation of equivalency in the rate of absorption of immediate release formulations. The applicability of the method was demonstrated with four drugs with different pharmacokinetic/pharmacodynamic characteristics. The confidence interval approach currently employed for bioequivalence determinations was applied to the relevant absorption parameters, including C _max and partial AUCs. The method was found to be more discriminating than C _max and/or T _max in the evaluation of the absorption rate of drugs. The cutoff time or point for partial AUC calculation may vary with the type of drug under study, depending on its clinical use and onset of action. The method was shown to be useful in the assessment of rate of absorption in bioequivalence studies.     

Past,Present, and Future of Bioequivalence: Improving Assessment and Extrapolation of Therapeutic Equivalence for Oral Drug Products

The growth in the utilization of systems thinking principles has created a paradigm shift in the regulatory sciences and drug product development. Instead of relying extensively on end product testing and one-size-fits-all regulatory criteria, this new paradigm has focused on building quality into the product by design and fostering the development of product-specific, clinically relevant specifications. In this context, this commentary describes the evolution of bioequivalence regulations up to the current day and discusses the potential of applying a Bayesian-like approach, considering all relevant prior knowledge, to guide regulatory bioequivalence decisions in a patient-centric environment.     

Substance abuse and the family: An examination of the South African policy context

National policy documents are important platforms for the prioritisation of social issues which is likely to spur research into the development of evidence-based practice guidelines that are effective and cost-efficient. In relation to the impact of substance abuse on the family, carefully designed policies that magnify support for the family can help lessen the burden of substance abuse on families. Using the Family Impact Lens (FIL) framework, this paper explored how family issues in relation to substance abuse are addressed within three South African policy and strategic documents: the Prevention of and Treatment for Substance Abuse (PTSA) Act (2008), the National drug master plan (NDMP; 2013–2017) and the White paper on families in South Africa (2012). In keeping with the framework of the FIL, we evaluated whether the policies (1) mention the effects of substance abuse on the family, (2) recognise the importance of the family in the relative’s rehabilitation and (3) address the needs of family members by providing policy directives to support families who are affected by substance abuse (affected family members (AFMs)). Although all three policies recognise that families are negatively impacted by a relative’s substance abuse, the policies are overly focussed on individual approaches to deal with substance abuse and fail to adequately address the support needs of AFMs. Research on the support needs of AFMs is warranted in addition to the evaluation or development of evidence-based strategies to support AFMs. Further implications and recommendations for policy-makers, researchers and practitioners are provided in the paper.     

Plant species used in the treatment of diabetes by South African traditional healers: An inventory

The indigenous people of southern Africa have a long history of traditional plant usage for medicinal purposes, with about 4,000 taxa being so employed. Traditional medicines continue to play a significant role in the treatment of life-threatening diseases such as malaria, tuberculosis, diabetes and AIDS in the developing world, although no adequate scientific evidence has been documented in support of their healing properties. The primary goal of this paper is to summarize information on some of the plant species used by traditional healers for the treatment of diabetes in South Africa. The information obtained is from published literature as well as personal communication with various traditional healers and herbalists from different areas. In total, the information of 32 plant species, representing 20 families, traditionally used by healers in the treatment of diabetes, has been discussed, of which 14 are currently being investigated for their hypoglycemic activity by various scientists at the University of Pretoria.     

Combined Exposure to Multiple Mycotoxins: An Example of Using a Tiered Approach in a Mixture Risk Assessment

Humans are exposed to mycotoxins on a regular basis. Exposure to a mixture of mycotoxins may, therefore, result in a combination of adverse effects, or trigger the same effects. This should be accounted for when assessing the combined risk of multiple mycotoxins. Here, we show the outcome of using different approaches in assessing the risks related to the combined exposure to mycotoxins. We performed a tiered approach using assessment groups with a common target organ (kidney, liver and haematologic system), or a common adverse effect (phenomenon) (reduced white blood cell count), to combine the exposure to mycotoxins. The combined exposure was calculated for the individuals in this assessment, using the Monte Carlo Risk Assessment (MCRA) tool. The risk related to this combined exposure was assessed using toxicological reference values, e.g., health based guidance values. We show that estimating the combined risk by adding the single compounds’ risk distributions slightly overestimates the combined risk in the 95th percentile, as compared to combining the exposures at an individual level. We also show that relative potency factors can be used to refine the mixture risk assessment, as compared to ratios of toxicological reference values with different effect sizes and assessment factors.