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Bioinformatics Tools and Software in Clinical Research
Published in Rishabha Malviya, Pramod Kumar Sharma, Sonali Sundram, Rajesh Kumar Dhanaraj, Balamurugan Balusamy, Bioinformatics Tools and Big Data Analytics for Patient Care, 2023
Deepika Bairagee, Nitu Singh, Neelam Jain, Urvashi Sharma
Pharmacovigilance is a pharmacological method for detecting, assessing, analyzing, and preventing drug side effects, particularly long and short-term unfavorable effects. Typically, pharmacovigilance refers to the technology of collecting, recording, researching, assessing, and evaluating data from doctors and patients on the adverse effects of drugs, biologics, herbal medicine, and traditional remedies with the purpose of:Identifying new drug hazards;Protecting patients from injury.Pre-marketing (medical phase) and post-marketing pharmacovigilance are the most prevalent types of pharmacovigilance, which begin in the clinical phase and continue throughout the product life cycle for the medicine. The process of collecting a huge number of such details regarding a pharmaceutical begins in Phase I of this medical trial and continues even after approval; a few post-market safety scientific investigations are typically undertaken, with several deemed mandatory by drug regulating corporations around the world [53].
Pharmacovigilance of Biosimilars
Published in Laszlo Endrenyi, Paul Jules Declerck, Shein-Chung Chow, Biosimilar Drug Product Development, 2017
Shehla Hashim, Souleh Semalulu, Felix Omara, Duc Vu
The World Health Organization (WHO) defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. The goals of pharmacovigilance are to identify and evaluate safety signals and to mitigate the risks of each product, in a timely manner” (WHO, 2002).
Regulatory considerations in biosimilars: Latin America region
Published in Preparative Biochemistry & Biotechnology, 2021
Anurag S. Rathore, Ankita Bhargava
The essential dossier submission requirements for bio-comparables are the preclinical and clinical trial data, certificates of good manufacturing practices (GMP) of the active pharmaceutical ingredient, and the biotherapeutic product, analytical methods, summaries, manufacturing license, prescribing information, label, and a pharmacovigilance program.[10] Apart from this, the bio-comparable manufacturer has to submit in vitro studies/comparative non-clinical studies, a report of the comparative Pharmacokinetics (PK), Pharmacodynamics (PD) test reports, and comparative efficacy and safety clinical test to show the similarity between the biosimilar and the RP. Once approved, adequate pharmacovigilance (PV) needs to be in place.[11]
Regulatory considerations in biosimilars: Asia pacific regions
Published in Preparative Biochemistry & Biotechnology, 2021
Anurag S. Rathore, Ankita Bhargava
In 2015, National Agency for Drug and Food Control (NADFC) of Republic of Indonesia launched the biosimilar guidelines (Perka BPOM RI No 17/2015). The guidelines contain detailed information regarding registration procedures and evaluation of biosimilar products including comparability studies, selection of RP, production process, physicochemical characterization, analytical techniques, non-clinical and clinical safety and efficacy evaluation as well as pharmacovigilance. For biosimilar characterization, the NADFC guidelines align with ICH including ICH Q5E (Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process) and ICH Q6B (Specification: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products).[20]