Results 121 to 130 of about 51,036 (300)

PHARMACOVIGILANCE IN INDIA: PERSPECTIVES AND PROSPECTS [PDF]

, 2013
In the scenario of ever-increasing range and potency of medicines, safety of medicines is one of the key parameters along with therapeutic efficacy for success of any drug.
Kumar, Sumit, Baldi, Ashish
core   +1 more source

Cell and Gene Therapies Manufacturing Challenges and Integrated Good Manufacturing Practices Solutions: A Lifecycle Perspective

Biotechnology and Bioengineering, EarlyView.
Lifecycle perspective on cell and gene therapy manufacturing challenges and enabling GMP solutions. ABSTRACT Cell and gene therapies (CGTs) are revolutionizing modern medicine; however, making these advanced medicines scalable and readily available to commercial manufacturers worldwide is a major challenge. The number of approved CGT products continues
Rajath Samaga, Udisha Singh, Sachin Dattram Pawar   +2 more
wiley   +1 more source

ON THE SUBJECT OF PHARMACOVIGILANCE

, 2015
On the subject of pharmacovigilance.
M. A. Murashko
core   +1 more source

Pharmacovigilance [PDF]

, 2017
The lecture is focused on monitoring the safety of medicines, which is also known as, pharmacovigilance which includes all activities related to the detection, assessment, understanding and prevention of adverse effects and other possible drug-related ...
Drakalska, Elena, Angelovska, Bistra
core   +1 more source

A White Paper on Advancing Long‐Acting Therapeutics for Maternal and Pediatric Health by Bridging Gaps in Clinical Research, Access and Regulation

Clinical Pharmacology &Therapeutics, EarlyView.
As use cases for long‐acting therapeutics expand across clinical indications, there is a critical need to ensure the inclusion of women who are pregnant or breastfeeding, infants and children—populations with a historical gap in the availability of interventions already approved for use in adults.
Moherndran Archary, Robert Bies, Osei Boateng, Rachel Daley, Pierre Gashema, Mili Karina, Emily Njuguna, Sharon Nachman, Nathaniel Nkrumah, Carolyne Odula, Andrew Owen, Ethel D. Weld, Prajith Venkatasubramanian, Adeniyi Olagunju, on behalf of the Community of Practice for Long‐acting Therapeutics for Maternal and Paediatric Health, Rana Abutaima, Dorothy Akongo, Abdulnaser Alsharaa, Moherndran Archary, Shakir Atoyebi, Benoit Bestgen, Robert Bies, Osei Boateng, Andrew Butler, Edmund Capparelli, Rachel Daley, Layla Davies, Joelle Dountio, Henry Enzama, Pierre Gashema, Katila George, Dan Hawcutt, Rene Holm, Patrick Gad Iradukunda, Elodie Jambert, Mili Karina, Linda Lewis, Grace Miheso, Sebastien Morin, Andrew Morrison, Sharon Nachman, Shadia Nakalema, Emily Njunga, Nathaniel Nkrumah, Carolyne Odula‐Obonyo, Brenda Okware, Adeniyi Olagunju, Andrew Owen, Martina Penazzato, Natella Rakhmanina, Mphako Brighton Ratlabyana, Rachel Scott, Kimberly Struble, Andre‐Marie Tchouatieu, Catherine Unsworth, Prajith Venkatasubramanian, Catriona Waitt, Ethel Weld, Janine Winterbottom, Leena Zino   +59 more
wiley   +1 more source

Understanding causes of incomplete reports of adverse drug reactions associated with dolutegravir-based HIV treatment in uganda: a qualitative study

BMC Infectious Diseases
Introduction Although dolutegravir (DTG)-based HIV treatment has demonstrated superior efficacy, it has been associated with adverse drug reactions (ADRs).
Henry Zakumumpa, Helen Byomire Ndagije, Joanitah Atuhaire, Julius Mayengo, Francis Odipiyo, Kiguba Ronald   +5 more
doaj   +1 more source

Pharmacovigilance [PDF]

, 2012
A report on the ‘National Symposium on Pharmacovigilance – 2011’ held at KLE University’s JN Medical College, Belgaum on 12th April ...
Patil, P A, Majagi, Suneel I
core  

Digital Transformation of Medicines Regulation in Africa—Perspectives from a Stakeholder Convening

Clinical Pharmacology &Therapeutics, EarlyView.
Regulatory authorities worldwide are developing strategies to integrate artificial intelligence (AI) into the lifecycle of health products, technologies, and medicines. While regulators share goals of improving efficiency, strengthening decision‐making, and protecting public health, their approaches differ according to institutional structures ...
Christelna Reyneke, Boitumelo Semete‐Makokotlela, Varnika Singh, Khanyisile Nkuku, Madelein Terblanche, Ezekiel T Mukanga, Nancy Ngum, Kudakwashe Dandajena, McNeil Chimus Mhango, Paulyne Wairimu, John Mwangi, Dominique Lagrave, Goonaseelan (Colin) Pillai   +12 more
wiley   +1 more source

Estimated Incidence of Hospitalizations and Deaths Attributable to Respiratory Syncytial Virus Infections Among Adults in Germany Between 2015 and 2019

Infectious Diseases and Therapy
Introduction Respiratory syncytial virus (RSV) burden in adults is underestimated mainly due to unspecific symptoms and limited standard-of-care testing.
Aleksandra Polkowska-Kramek, Elizabeth Begier, Robin Bruyndonckx, Caihua Liang, Caroline Beese, Gordon Brestrich, Thao Mai Phuong Tran, Charles Nuttens, Maribel Casas, Lea Johanna Bayer, Bennet Huebbe, Worku Biyadgie Ewnetu, Juan Luis Ramirez Agudelo, Bradford D. Gessner, Christof von Eiff, Gernot Rohde   +15 more
doaj   +1 more source

Regulatory Research Priorities for AI Use in the Medicine Lifecycle: A European Perspective with Global Relevance

Clinical Pharmacology &Therapeutics, EarlyView.
Regulatory bodies play a central role in providing guidance that enables safe and effective use of artificial intelligence tools in medicine development and evaluation. Regulators can also act as catalysts for regulatory science research. To inform these efforts, a European‐wide survey was conducted to solicit stakeholder perspectives on the priority ...
Luis C. Pinheiro, Amanda C. Langston, Marie Orre, Joerg Zinserling, Konstantina Boumaki, Bastian V. H. Hornung, Siobhan O'Sullivan, Gabriel Westman, Karl Broich, Peter Arlett   +9 more
wiley   +1 more source