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7,212 results

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The following term was not found in PubMed: Biogenerics-need
Page 1
Regulatory options for genetically modified crops in India.
Choudhary B, Gheysen G, Buysse J, van der Meer P, Burssens S. Choudhary B, et al. Plant Biotechnol J. 2014 Feb;12(2):135-46. doi: 10.1111/pbi.12155. Plant Biotechnol J. 2014. PMID: 24460889 Free article. Review.
The development of GM mustard discontinued prematurely in 2001 and insect-resistant Bt cotton varieties were successfully approved for commercial cultivation in 2002 in an evolving nature of regulatory system. ...This study examines what ails the regulatory s …
The development of GM mustard discontinued prematurely in 2001 and insect-resistant Bt cotton varieties were successfully approved fo …
Regulatory approval process for advanced dressings in India: an overview of rules.
Yadav V, Mittal A, Bansal P, Singh SK. Yadav V, et al. J Wound Care. 2019 Aug 1;28(Sup8):S32-S42. doi: 10.12968/jowc.2019.28.Sup8.S32. J Wound Care. 2019. PMID: 31393785 Review.
The concept of advanced dressings is emerging in India. However, local manufacturing is hindered by an absence of clear regulatory guidelines. ...Thus development of clear quality regulatory guidelines is crucial. Therefore, this article may guide and …
The concept of advanced dressings is emerging in India. However, local manufacturing is hindered by an absence of clear regulatory …
Efficacy and Safety of Sovateltide in Patients with Acute Cerebral Ischaemic Stroke: A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase III Clinical Trial.
Gulati A, Adwani SG, Vijaya P, Agrawal NR, Ramakrishnan TCR, Rai HP, Jain D, Sundarachary NV, Pandian JD, Sardana V, Sharma M, Sidhu GK, Anand SS, Vibha D, Aralikatte S, Khurana D, Joshi D, Karadan U, Siddiqui MSI. Gulati A, et al. Drugs. 2024 Dec;84(12):1637-1650. doi: 10.1007/s40265-024-02121-5. Epub 2024 Nov 15. Drugs. 2024. PMID: 39542995 Free PMC article. Clinical Trial.
CONCLUSIONS: The sovateltide group had a greater number of cerebral ischaemic stroke patients with lower mRS and NIHSS scores at 90 days post-treatment than the control group. This trial supported the regulatory approval of sovateltide in India, but a multinational …
CONCLUSIONS: The sovateltide group had a greater number of cerebral ischaemic stroke patients with lower mRS and NIHSS scores at 90 days pos …
A history of thalidomide in India.
Wimmelbücker L, Kar A. Wimmelbücker L, et al. Med Hist. 2023 Jul;67(3):228-246. doi: 10.1017/mdh.2023.27. Epub 2023 Sep 5. Med Hist. 2023. PMID: 37668377 Free PMC article.
This article challenges this view by showing that the drug entered the Indian subcontinent through the former Portuguese territory of Goa around 1960. We examine the subsequent development of its distribution, use and regulation in India from the mid-1960s up to the …
This article challenges this view by showing that the drug entered the Indian subcontinent through the former Portuguese territory of Goa ar …
Biosimilars in India.
Rathore AS. Rathore AS. J Proteomics. 2015 Sep 8;127(Pt A):71-2. doi: 10.1016/j.jprot.2015.08.005. Epub 2015 Aug 13. J Proteomics. 2015. PMID: 26277742 Review.
India is globally regarded to have great potential to become a significant player in development and commercialization of biosimilars. This short communication aims to provide a brief discussion on where India is with respect to development and commerc …
India is globally regarded to have great potential to become a significant player in development and commercialization of bios …
Regulatory landscape and challenges in CAR-T cell therapy development in the US, EU, Japan, and India.
S S KD, Joga R, Srivastava S, Nagpal K, Dhamija I, Grover P, Kumar S. S S KD, et al. Eur J Pharm Biopharm. 2024 Aug;201:114361. doi: 10.1016/j.ejpb.2024.114361. Epub 2024 Jun 11. Eur J Pharm Biopharm. 2024. PMID: 38871092 Review.
The present work comprehensively analyses the regulatory landscape and challenges in CAR-T cell therapy development in four key regions: the United States, the European Union, Japan, and India. ...However, India's first indigenously developed …
The present work comprehensively analyses the regulatory landscape and challenges in CAR-T cell therapy development in four ke …
Development of Pharmacovigilance System in India and Paradigm of Pharmacovigilance Research: An Overview.
Singh P, Vaishnav Y, Verma S. Singh P, et al. Curr Drug Saf. 2023;18(4):448-464. doi: 10.2174/1574886317666220930145603. Curr Drug Saf. 2023. PMID: 36200243 Review.
Presently, 567 ADR Monitoring Centres (AMC) are functioning under PvPI across India. The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services (DGHS), and the Ministry of Health, Family & Welfare (MoHFW) Government of …
Presently, 567 ADR Monitoring Centres (AMC) are functioning under PvPI across India. The Central Drugs Standard Control Organization …
Brain banking in India: Relevance in current day practice.
Shankar SK, Mahadevan A. Shankar SK, et al. Indian J Pathol Microbiol. 2022 May;65(Supplement):S218-S225. doi: 10.4103/ijpm.ijpm_113_22. Indian J Pathol Microbiol. 2022. PMID: 35562152 Free article. Review.
The ethics of biobanking is one of the most controversial issues in bioethics, the key issues being consent, confidentiality, and commercialisation. Regulatory authorities in different countries and in India, the Indian Council of Medical Research has taken a lead t …
The ethics of biobanking is one of the most controversial issues in bioethics, the key issues being consent, confidentiality, and commercial …
Similar biologics in India: A story of access or potential for compromise?
Jois R, Mukherjee S, Rajeswari S, Rath PD, Goyal V, Gupta D. Jois R, et al. Indian J Med Res. 2020 Nov;152(5):456-467. doi: 10.4103/ijmr.IJMR_43_18. Indian J Med Res. 2020. PMID: 33707387 Free PMC article. Review.
The Indian Regulatory Authorities in July 2012 developed the first guidelines for approval of similar biologics, which comprised requirements for the manufacturing process, quality evaluation, preclinical and clinical studies, as well as post-marketing studies. The …
The Indian Regulatory Authorities in July 2012 developed the first guidelines for approval of similar biologics, which compris …
Use of plant extracts for tea pest management in India.
Roy S, Handique G, Muraleedharan N, Dashora K, Roy SM, Mukhopadhyay A, Babu A. Roy S, et al. Appl Microbiol Biotechnol. 2016 Jun;100(11):4831-44. doi: 10.1007/s00253-016-7522-8. Epub 2016 Apr 22. Appl Microbiol Biotechnol. 2016. PMID: 27102124 Review.
India is the second largest producer of black tea in the world. The biggest challenge for tea growers of India nowadays is to combat pests and diseases. ...Apart from systematic research in this area, to facilitate the simplified and trade friendly registration proc …
India is the second largest producer of black tea in the world. The biggest challenge for tea growers of India nowadays is to …
7,212 results