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n protection policies.Recombinant drug products successfully treat many life-threatening and chronic diseases. The high cost of these drugs makes them inaccessible to the patients particularly in developing countries. Patent expiration of innovator recombinant drug products has led to the development of biosimilars or similar biologics by several manufacturers. Unlike generics, these are not identical to their innovator products because of the differences in the manufacturing process; however, they are similar in quality characteristics, biological activity, safety, and efficacy. The regulatory procedures used for generic drugs cannot be applied for biosimilars as they are large complex structures produced from living cells and can produce potential risk of immune-based adverse reactions. Out of several safety issues related to biosimilars, two main safety concerns are variable potency and immunogenicity, for which a robust long-term pharmacovigilance system is needed. Various guidelines have been issued for the regulatory approval and pharmacovigilance of biosimilars by USFDA, EU, and pharma-emerging countries like China and India. The article includes the pharmacovigilance plan of biosimilars in these countries, discusses the challenges and opportunities in pharmacovigilance through spontaneous reporting systems, and suggests amendments in the existing suspected adverse event reporting form of the Pharmacovigilance Programme of India.

Cohen’s kappa is a statistic that estimates interobserver agreement. It was originally introduced to help develop diagnostic tests. Interpretative readings of 2 observers, for example, of a mammogram or other imaging, were compared at a single point in time. It is known that kappa depends on the prevalence of disease and that, therefore, kappas across different settings are hard to compare.

Using simulation, we examine an analogous situation, not previously described, that occurs in clinical trials where sequential measurements are obtained to evaluate disease progression or clinical improvement over time.

We show that weighted kappa, used for multilevel outcomes, changes during the trial even if we keep the performance of the observer constant.

Kappa and closely related measures can therefore only be used with great difficulty, if at all, in quality assurance in clinical trials.

Kappa and closely related measures can therefore only be used with great difficulty, if at all, in quality assurance in clinical trials.

Self-management can be considered a way of dealing with oneself and relates to actions undertaken to create order, discipline, and control. The concept is closely linked to concepts of self-efficacy and self-regulation but can be distinguished from these. The Self-Management Self-Test (SMST) is a 5-item assessment scale designed to measure self-management competence in individuals with or without a psychiatric disorder (as screened using PHQ). The aim of this study was to validate the SMST in terms of convergent validity, the ability to differentiate, criterion validity, internal consistency, and test-retest reliability.

Eighty-seven adults hospitalized for treatment of major depression (clinical sample) and 595 individuals from the general population (population sample) filled out the SMST and 5 other stress-related psychometric instruments measuring similar constructs. All instruments were repeated 4 to 6 weeks later. Convergent validity, internal consistency, and test-retest reliability were tested bas evaluating patient-reported outcomes.An examination for potential direct or indirect adverse effects on the immune system (immunotoxicity) is an established component of nonclinical testing to support safe use of new drugs. Testing recommendations occur in various regulatory guidance documents, especially ICH S8, and these will be presented. Key evaluation usually occurs in toxicology studies with further investigative work a consideration if a positive signal is seen. Expectations around whether findings may occur are related to the type of compound being developed, including a chemically synthesized small molecule, a small molecule oncology drug, a biopharmaceutical, an oligonucleotide, a gene therapy/stem cell product, a vaccine, or reformulation of drugs in liposomes or depots. Examples of immunotoxicity/immunogenicity findings will be discussed for all of these types of compound. Overall, it can be concluded that our main tool for evaluation of potential immunotoxicity/immunogenicity for a new drug still remains standard toxicology study testing with key assessment for effects on clinical pathology and lymphoid organs/tissues (weights and cellularity). Additional evaluation from studies using a T cell-dependent antibody response (TDAR) and lymphocyte phenotyping is also valuable, if needed. ML198 price Thus, using the tools from the past, it is the role of toxicologists to work with clinical teams now and in the future, to interpret findings from nonclinical testing to possible adverse findings in humans.The purpose of the present review is to summarize the current pediatric regulatory requirements and also the regulatory efforts that need to be taken for the potential benefits of safety and efficacy to the pediatric patients. The importance of pediatric regulations came into existence as adult physiological conditions differ from that of children; therefore, the same dosage regimen cannot be recommended for both. Children deviate from adults with respect to pharmacokinetic and pharmacodynamic characteristics, and hence the effect of the drug has to be reconfirmed for pediatrics. Drugs used in pediatric clinics are often considered as “therapeutic orphans” throughout the world as they are difficult to develop and are not provided with sufficient information. The number of clinical trials performed in children is not sufficient. At present, laws and regulations aimed at drug development in the pediatric field have not been focused significantly. There are different regulatory bodies that administrate the pediatric regulations for a particular region.

Despite the regulatory requirement for cooperation between marketing authorization holders (MAHs) and European Medicines Agency (EMA) in the direct healthcare professional communication (DHPC) preparation, no literature has explored DHPCs from an industry-regulator perspective. This constitutes a significant knowledge gap as any possibility of improving current DHPC effectiveness depends on decisions in the cooperative preparation phase. Thus, this EU-centered study explores differences in perceptions and experiences of DHPCs of European MAHs and EMA.

European MAHs ([Formula see text]) and EMA representatives ([Formula see text]) were interviewed. The verbatim transcripts were coded into themes using NVivo software. Interview analysis was performed following a phenomenological approach of meaning condensation.

The DHPC process was perceived as burdensome by the industry. One company stated the process was time-consuming either due to EMA’s internal lengthy approval process or the translation activities with local company affiliates and national competent authorities.