Ashish Shedage

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PMC/PubMed Indexed Articles

Statistical considerations in biosimilar assessment using biosimilarity index

In-vitro Release of Rapamycin from a Thermosensitive Polymer for the Inhibition of Vascular Smooth Muscle Cell Proliferation

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Citations : 4363

Journal of Bioequivalence & Bioavailability received 4363 citations as per Google Scholar report

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Ashish Shedage

Ashish Shedage

Department of Clinical and Bioequivalence Research, Cipla Limited, R &D, Center, LBS Marg, Vikhroli (W), Mumbai 400 083, India

Biography

Cipla Limited · Regulatory medical writing- CRD 14 years of experience in Regulatory medical writing, Global labeling, Pharmacovigilance, Agreegate safety report like PBRER, DSUR, Clinical trials writing,eTMF, BA/BE, Pre-clinical DMPK. Responsible for medical writing and sign off in support of product registration and life cycle globally. Well oriented with CTD guidelines, Global labeling guidelines, Pharmacovigilance guidelines, Aggregate Safety reporting.