Results 51 to 60 of about 5,946 (190)

An international initiative to create a collaborative for pharmacovigilance in hospice and palliative care clinical practice [PDF]

, 2012
Background: Medication registration currently requires evidence of safety and efficacy from adequately powered phase 3 studies. Pharmacovigilance (phase 4 studies, postmarketing data, adverse drug reaction reporting) provide data on more widespread and
Abernethy, Amy Pickar, Currow, David Christopher, Doogue, Matthew, Rowett, Debra Sharon, To, Timothy H M   +4 more
core   +1 more source

LC-Q-TOF-MS driven identification of potential degradation impurities of venetoclax, mechanistic explanation on degradation pathway and establishment of a quantitative analytical assay method

Journal of Analytical Science and Technology, 2020
Venetoclax is a selective orally active Bcl-2 protein inhibitor very recently approved by USFDA to treat chronic lymphocytic leukemia and other hematological malignancies.
Dhruvisha Pokar, Amit Kumar Sahu, Pinaki Sengupta   +2 more
doaj   +1 more source

Toxicological Evaluation of the Undesirable Components in Processed Infant Foods Using Artificial Intelligence

Future Postharvest and Food, EarlyView.
The detection of toxins in baby food using artificial intelligence. ABSTRACT Infant foods and baby formulas are becoming increasingly popular across the globe owing to their ease of consumption and nutritional value specific to infants. Impurities may find their way into the food chain at any point from the acquisition of raw materials to final ...
Poornima Singh, Anurag Singh, Ashutosh Upadhyay, Navneet Kumar   +3 more
wiley   +1 more source

The US Food and Drug Administration’s expedited approval programs: addressing premarket flexibility with enhanced postmarket evidence generation [PDF]

, 2018
When the editors of Clinical Trials solicited our review on the U.S. Food and Drug Administration’s (FDA) expedited development and review programs, we anticipated there would be accompanying commentaries from other academics with differing opinions, or ...
Naci, Huseyin, Ross, Joseph S., Wallach, Joshua D.   +2 more
core   +2 more sources

The Science of Safety – An Emerging Concept in Medication Use and Research

INNOVATIONS in Pharmacy, 2016
Most published reports of patient safety in clinical practice focus largely on the culture of safety in complex health systems, separate from pre-approval and postmarketing research-related safety considerations for drugs, biologics, and other medical ...
Shraddha Shinde, MBA student, Stephanie Y Crawford, PhD   +1 more
doaj   +1 more source

Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situations [PDF]

Farmacia Hospitalaria, 2018
Objective: To know the safety profile of the 4CMenB vaccine in adults in special situations. Method: Security prospective study of phase IV. Inclusion criteria and some vaccination conditions were applied.
María Fernández-Prada, Carmen Martínez-Ortega, Lara Hidalgo-Peña, Clara Álvarez-Vázquez, Rodrigo Aguirre-del Pino, Ismael Huerta-González   +5 more
doaj   +1 more source

Collagen‐membrane‐covered matrix‐associated chondrocyte implantation improves safety over periosteum‐covered MACI for large knee cartilage defects: A real‐world data analysis in the registry study

Knee Surgery, Sports Traumatology, Arthroscopy, EarlyView.
Abstract Purpose This registry study aimed to evaluate the safety and effectiveness of collagen membrane‐covered matrix‐associated autologous chondrocyte implantation (cMACI) versus periosteum‐covered MACI (pMACI) for large knee cartilage defects (Outerbridge III–IV, ≥4 cm²) in the femorotibial and/or patellofemoral joints with a minimum 2‐year follow ...
Yuji Uchio, Ryosuke Kuroda, Yasuo Niki, Katsura Sugawara, Yasuyuki Ishibash   +4 more
wiley   +1 more source

Safety of opioid patch initiation in Australian residential aged care [PDF]

, 2015
Explores opioid use by aged care facility residents before and after initiation of transdermal opioid patches. Abstract Objective: To explore opioid use by aged care facility residents before and after initiation of transdermal opioid patches. Design:
Elizabeth Roughead, Lisa Pont, Svetla Gadzhanova   +2 more
core   +1 more source

2024 update on postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia

Archives of Medical Science
Introduction Considering lack of a European standardized postmarketing food supplement surveillance system (nutrivigilance), some member states and companies have developed their own approaches to monitoring potential adverse reactions (AEs) to secure a ...
Maciej Banach, Niki Katsiki, Gustavs Latkovskis, Dan Gaita, Carlos Escobar, Daniel Pella, Peter E. Penson, Federica Fogacci, Zeljko Reiner, Arrigo F.G. Cicero   +9 more
doaj   +1 more source

Japanese Clinical Practice Guidelines for Vascular Tumors, Vascular Malformations, Lymphatic Malformations, and Lymphangiomatosis 2022

The Journal of Dermatology, EarlyView.
ABSTRACT The objective was to prepare guidelines to perform the current optimum treatment by organizing effective and efficient treatments of hemangiomas and vascular malformations, confirming the safety, and systematizing treatment, employing evidence‐based medicine techniques and aimed at improvement of the outcomes.
Yoshiaki Kinoshita, Kosuke Ishikawa, Sadanori Akita, Katsuyoshi Koh, Satoru Sasaki, Masatoshi Jinnin, Hidefumi Mimura, Keigo Osuga, Michio Ozeki, Michiko Nagahama, Akihiro Fujino, Yoko Aoki, Akiko Asai, Noriko Aramaki‐Hattori, Ryohei Ishiura, Masanori Inoue, Yuki Iwashina, Takafumi Ohshiro, Keiko Ogawa, Mine Ozaki, Junko Ochi, Shiro Onozawa, Motoi Kato, Takahide Kaneko, Tamihiro Kawakami, Akira Kitagawa, Masakazu Kurita, Yoshihiro Kuwano, Taro Kono, Shien Seike, Shinsuke Takagi, Nobuyuki Takakura, Takao Tachibana, Shuichi Tanoue, Kumiko Chuman, Hiroki Nakaoka, Yasuhiro Nakamura, Fumio Nagai, Yasunari Niimi, Shunsuke Nosaka, Taiki Nozaki, Tadashi Nomura, Kazuki Hashimoto, Ayato Hayashi, Satoshi Hirakawa, Takeshi Hirabayashi, Taizo Furukawa, Hiroshi Furukawa, Yumiko Hori, Takanobu Maekawa, Kentaro Matsuoka, Hideki Mori, Eiichi Morii, Akira Morimoto, Yuta Moriwaki, Shunsuke Yuzuriha, Naoaki Rikihisa, Munezumi Fujita, Yasuyuki Yamahana, Kyoichi Deie, Asami Tozawa, Daisuke Hasegawa, Akira Higashiyama, Daisuke Maeda, Sachiko Asayama, Yuhki Arai, Yohei Iwata, Mayu Uka, Hidehito Usui, Mizuki Uchiyama, Saori Endo, Hideki Endo, Rintaro Ono, Naoya Oshima, Toshihiro Otsuka, Kuniaki Ohara, Shinji Kagami, Tomo Kakihara, Mototoshi Kato, Hiroki Kanamori, Masafumi Kamata, Ami Kawaguchi, Akiko Kishi, Hiroshi Kitagawa, Kiyokazu Kim, Tamotsu Kobayashi, Takeshi Saito, Yusuke Shikano, Shuichi Shimada, Keisuke Suzuki, Masataka Takahashi, Shohei Takami, Reiko Takeda, Aya Tanaka, Kaishu Tanaka, Satoru Tamura, Masashi Tamura, Kanako Danno, Kenji Tsuboi, Yuta Nakajima, Ryo Nakatani, Miho Noguchi, Akifumi Nozawa, Naoki Hashizume, Masashi Hayakawa, Daichi Hayashi, Takaya Fukumoto, Mamoru Honda, Norifumi Matsuda, Hayato Maruguchi, Naoki Murakami, Kiichiro Yaguchi, Shiho Yasue, Hiroki Yoshihara, Rika Yoshimatsu, Kiyohito Yamamoto, Shinji Wada   +116 more
wiley   +1 more source