Safety assessment of biopharmaceuticals: Japanese perspective on ICH S6 guideline maintenance

Considerations regarding nonhuman primate use in safety assessment of biopharmaceuticals.

Selection of a pharmacologically responsive species can represent a major challenge in designing nonclinical safety assessment programs for many biopharmaceuticals (eg, monoclonal antibodies (mAbs)). Frequently, the only relevant species for nonclinical testing of mAbs is the non-human primate (NHP). This situation, coupled with a rapidly increasing number of mAb drugs in development, has resul...

"Points to consider" regarding safety assessment of biotechnology-derived pharmaceuticals in non-clinical studies (English translation).

Regulatory and industrial scientists collaborated to publish a "points to consider" document regarding the safety assessment of biotechnology-derived pharmaceuticals in non-clinical studies in 2002 (Pharmaceutical Non-clinical Investigation Group, 2002). The collaboration team intended to clarify the interpretation of ICH-S6 guideline and furthermore share recent Japanese practices on this matt...

the impact of training on second language writing assessment: a case of raters’ biasedness

چکیده هدف اول این تحقیق بررسی تأثیر آموزش مصحح بر آموزش گیرندگان براساس پایایی نمره های آنها در پنج بخش شامل محتوا ، سازمان ، لغت ، زبان و مکانیک بود. هدف دوم این بود که بدانیم آیا تفاوتهای بین آموزشی گیرندگان زن و مرد در پایایی نمرات آنها وجود دارد. برای بررسی این موارد ، ما 90 دانشجو در سطح میانه (متوسط) که از طریق تست تعیین سطح شده بودند انتخاب شدند. بعد از آنها خواستیم که درباره دو موضوع ا...

Assessment of distance-based multi-attribute group decision-making methods from a maintenance strategy perspective

Maintenance has been acknowledged by industrial management as a significant influencing factor of plant performance. Effective plant maintenance can be realized by developing a proper maintenance strategy. However, selecting an appropriate maintenance strategy is difficult because maintenance is a non-repetitive task such as production activity. Maintenance also does not leave a consistent trac...

ICH guideline S10 - Guidance on photosafety evaluation of pharmaceuticals - Step 3