RESUMEN
Pharmaceutic products designed to perturb the function of epigenetic modulators have been approved by regulatory authorities for treatment of advanced cancer. While the predominant effort in epigenetic drug development continues to be in oncology, non-oncology indications are also garnering interest. A survey of pharmaceutical companies was conducted to assess the interest and concerns for developing small molecule direct epigenetic effectors (EEs) as medicines. Survey themes addressed (1) general levels of interest and activity with EEs as therapeutic agents, (2) potential safety concerns, and (3) possible future efforts to develop targeted strategies for nonclinical safety assessment of EEs. Thirteen companies contributed data to the survey. Overall, the survey data indicate the consensus opinion that existing ICH guidelines are effective and appropriate for nonclinical safety assessment activities with EEs. Attention in the framework of study design should, on a case by case basis, be considered for delayed or latent toxicities, carcinogenicity, reproductive toxicity, and the theoretical potential for transgenerational effects. While current guidelines have been appropriate for the nonclinical safety assessments of epigenetic targets, broader experience with a wide range of epigenetic targets will provide information to assess the potential need for new or revised risk assessment strategies for EE drugs.
Asunto(s)
Industria Farmacéutica/normas , Control de Medicamentos y Narcóticos , Epigénesis Genética/efectos de los fármacos , Preparaciones Farmacéuticas/normas , Encuestas y Cuestionarios , Animales , Evaluación Preclínica de Medicamentos/normas , Evaluación Preclínica de Medicamentos/tendencias , Industria Farmacéutica/tendencias , Control de Medicamentos y Narcóticos/tendencias , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Epigénesis Genética/genética , Humanos , Preparaciones Farmacéuticas/administración & dosificación , Medición de Riesgo/normas , Medición de Riesgo/tendenciasRESUMEN
OBJECTIVE: To develop a new identification and analysis method of Chinese medicinal materia Liquoric Root. METHODS: Powder X-ray diffraction Fourier fingerprint pattern. RESULTS: Experiments and analysis were carried out on ten samples. The standard X-ray diffraction Fourier fingerprint pattern and characteristic diffraction peaks of Liquoric Root were obtained. CONCLUSION: This method can be used for identification of Chinese medicinal materia Liquoric Root.