Results 31 to 40 of about 32,756 (214)

A Phase 1, Randomized, Open‐Label, Parallel Group Study to Evaluate the Relative Bioavailability and Safety of Subcutaneous Bepirovirsen when Delivered from a Vial or Prefilled Syringe Fitted with a Safety Syringe Device in Healthy Adult Participants

Clinical Pharmacology in Drug Development, EarlyView.
Abstract Bepirovirsen, an antisense oligonucleotide in development for the treatment of chronic hepatitis B virus (HBV) infection, is administered from glass vials as a subcutaneous (SC) injection by healthcare professionals (HCPs). A ready‐to‐use prefilled syringe (PFS) assembled with a safety syringe device (SSD) has been developed to make ...
Amir S. Youssef, Poonam Shah, Maxwell Hu, Helene Plein, Abhishek Roy, Ravi Sharma, Sarah Mole, Magdalena Blazejczyk, Wendy Cross, Brian Spears, Samuel Pak, Rejbinder Kaur, Robert Elston, Dickens Theodore, Marjan Hezareh, Ahmed Nader   +15 more
wiley   +1 more source

The switch from patented medicine to the generic one: an option or a necessity? [PDF]

, 2018
This paper assesses the influence of a number of factors taken into account when a brand name drug is replaced by a generic one. It also evaluates responses of health professionals – physicians and pharmacist—and patients regarding the issue of switching.
Adriana Elena, Nica, Alexandra, Bolocan, Dan Nicolae, Păduraru, Daniel, Ion, Dumitru Cristinel, Badiu, Florentina, Coman, Marius, Coțofană, Octavian, Andronic, Valentin Titus, Grigorean   +8 more
core   +1 more source

The bioequivalence of fixed‐dose combination tablets of bisoprolol and ramipril and its drug‐drug interaction potential [PDF]

, 2021
Jan Sus, Jade Huguet, Jan Bosák, Beatrice Setnik, Tomáš Hauser, Éric Sicard   +5 more
openalex   +1 more source

Comparative Bioequivalence and Safety Evaluation of Ibuprofen/Phenylephrine Hydrochloride Fixed‐Dose Combination Tablets in Healthy Chinese Volunteers

Clinical Pharmacology in Drug Development, EarlyView.
Abstract This single‐center, randomized, open‐label bioequivalence program compared two fixed‐dose combination (FDC) tablets containing ibuprofen (200 mg) and phenylephrine hydrochloride (10 mg) from different manufacturers in healthy Chinese adults under fasting and fed conditions. A three‐period, partially replicated crossover design was used for the
Menghan Ye, Rui Zhang, Jing Wan, Jinping Zhou, Pengpeng Guo, Dianwen Yu, Peixia Li, Yani Liu, Shaojun Shi   +8 more
wiley   +1 more source

Non-equivalence of antibiotic generic drugs and risk for intensive care patients [PDF]

, 2013
Background: The underlying axiom in applying generic drugs is the equivalence of their active ingredient with the (usually more expensive) innovator product, an all-embracing statement with the insidious result that physicians assume that the generic ...
Barbeck, Mike, Ghanaati, Shahram, Kirkpatrick, Charles James, Rangoonwala, Ramzan, Reshetnykov, Mykhaylo   +4 more
core  

Capability Development in the European Medicines Regulatory Network—A European Learning Needs Analysis and Survey Study

Clinical Pharmacology &Therapeutics, EarlyView.
The European Medicines Regulatory Network plays a critical role in safeguarding public health through the assessment and supervision of human medicines. However, rapid scientific and technological advancements have exposed capability deficits across the network, threatening timely and effective regulatory decision‐making.
Naomi Beard, Marko J. Kallio, Luca Kosec, Ulrika Espefält Westin, on behalf of the IncreaseNET consortium   +4 more
wiley   +1 more source

In Vitro and Clinical Evaluation of Potential Interactions of Bemnifosbuvir with Drug Transporters

The Journal of Clinical Pharmacology, EarlyView.
Abstract Bemnifosbuvir is a novel oral guanosine nucleotide prodrug candidate for the treatment of chronic hepatitis C virus infection. Potential drug–drug interactions (DDIs) of bemnifosbuvir as a substrate or perpetrator with regard to ATP‐binding cassette (ABC) and solute carrier (SLC) transporters were evaluated in vitro and in clinical studies ...
Xiao‐Jian Zhou, Alex Vo, Gaetano Morelli, Maureen Montrond, Shannan Lynch, Keith Pietropaolo, Bruce Belanger, Arantxa Horga, Nancy Agrawal, Janet Hammond   +9 more
wiley   +1 more source

Phase 3b Extension Study MT‐1186‐A04 to Evaluate the Continued Efficacy and Safety of Edaravone Oral Suspension for Up to an Additional 48 Weeks in Patients With Amyotrophic Lateral Sclerosis

Muscle &Nerve, EarlyView.
ABSTRACT Introduction/Aims An On/Off dosing regimen of intravenous (IV) edaravone and edaravone oral suspension is currently approved in the US for treatment of amyotrophic lateral sclerosis (ALS). Placebo‐controlled clinical trials showed that IV edaravone slows physical functional decline.
Angela Genge, Jeffrey Rothstein, Shari De Silva, Lorne Zinman, Marvin Chum, Adriano Chiò, Gen Sobue, Masashi Aoki, Hiide Yoshino, Manabu Doyu, Daniel Selness, Vesna Todorovic, Manabu Hirai, Nissim Sasson, Fumihiro Takahashi, Michelle Cecić, Art Wamil, Stephen Apple   +17 more
wiley   +1 more source

Intranasal diamorphine population pharmacokinetics modeling and simulation in pediatric breakthrough pain

CPT: Pharmacometrics &Systems Pharmacology, Volume 14, Issue 3, Page 435-447, March 2025.
Abstract Intranasal diamorphine (IND), approved for managing breakthrough pain in the UK, has been identified as an acceptable alternative offering effective, expedient, and less traumatic analgesia for children. However, the current dose regimen in pediatric populations relies on clinical expertise while the pharmacokinetics properties are poorly ...
Lianjin Cai, Jingchen Zhai, Beihong Ji, Fengyang Han, Taoyu Niu, Luxuan Wang, Junmei Wang   +6 more
wiley   +1 more source

Testing for equivalence: an intersection-union permutation solution

, 2018
The notion of testing for equivalence of two treatments is widely used in clinical trials, pharmaceutical experiments,bioequivalence and quality control. It is essentially approached within the intersection-union (IU) principle.
Arboretti, R., Carrozzo, E., Pesarin, F., Salmaso, L.   +3 more
core   +1 more source