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Physicochemical stability of Cisplatin Accord in punctured original vials, syringes and after dilution with 0.9% sodium chloride solution
Physicochemical stability of Cisplatin Accord in punctured original vials, syringes and after dilution with 0.9% sodium chloride solution
Home » Articles » Volume 13 / Year 2024 / Issue 2 » Special Report » Physicochemical stability of Cisplat...
Physicochemical stability of Carboplatin Accord in punctured original vials, syringes and after dilution with 0.9% sodium chloride or 5% glucose solution
Physicochemical stability of Carboplatin Accord in punctured original vials, syringes and after dilution with 0.9% sodium chloride or 5% glucose solution
Home » Articles » Volume 13 / Year 2024 / Issue 2 » Special Report » Physicochemical stability of Carbopl...
Physicochemical stability of Cabazitaxel Accord in punctured original vials and after dilution with 0.9% sodium chloride or 5% glucose solution in non-PVC bottles
Physicochemical stability of Cabazitaxel Accord in punctured original vials and after dilution with 0.9% sodium chloride or 5% glucose solution in non-PVC bottles
Home » Articles » Volume 13 / Year 2024 / Issue 2 » Special Report » Physicochemical stability of Cabazit...
Physicochemical stability of Bortezomib Accord 2.5 mg/mL and diluted 1 mg/mL intravenous injection solution in punctured original vials and polypropylene syringes
Physicochemical stability of Bortezomib Accord 2.5 mg/mL and diluted 1 mg/mL intravenous injection solution in punctured original vials and polypropylene syringes
Home » Articles » Volume 13 / Year 2024 / Issue 2 » Special Report » Physicochemical stability of Bortezo...
Physicochemical stability of Azacitidine Accord 25 mg/mL suspension for injection in original vials and polypropylene syringes after reconstitution with refrigerated water for injection
Physicochemical stability of Azacitidine Accord 25 mg/mL suspension for injection in original vials and polypropylene syringes after reconstitution with refrigerated water for injection
Home » Articles » Volume 13 / Year 2024 / Issue 2 » Special Report » Physicochemical stability of Azaciti...
Transforming health care: CinnaGen’s leadership in follow-on biologicals/biosimilars development and market expansion
Transforming health care: CinnaGen’s leadership in follow-on biologicals/biosimilars development and market expansion
Home » Articles » Volume 13 / Year 2024 / Issue 3 » Interview » Transforming health care: CinnaGen’s lead...
A review of international initiatives on pharmaceutical regulatory reliance and recognition
A review of international initiatives on pharmaceutical regulatory reliance and recognition
Home » Articles » Volume 13 / Year 2024 / Issue 3 » Review Article » A review of international initiative...
Comment on the article by Reilly MS and McKibbin RD
Home » Articles » Comment on the article by Reilly MS and McKibbin RD ...
Comment on the article ‘Misinformation about interchangeable biosimilars’
Home » Articles » Comment on the article ‘Misinformation about interchangeable biosimilars’ ...
Third and final issue of GaBI Journal’s 13th volume
Home » Articles » Volume 13 / Year 2024 / Issue 3 » Editor's Letter » Third and final issue of GaBI Journ...
Biosimilar Red Tape Elimination Act (S.2305): weakening FDA regulatory standards for biosimilars, undermining physician confidence and jeopardizing patient health
Biosimilar Red Tape Elimination Act (S.2305): weakening FDA regulatory standards for biosimilars, undermining physician confidence and jeopardizing patient health
Home » Articles » Biosimilar Red Tape Elimination Act (S.2305): weakening FDA regulatory standards for bi...
Turkey’s biotech manufacturing ambitions: Yerlika Biopharma’s strategic role
Turkey’s biotech manufacturing ambitions: Yerlika Biopharma’s strategic role
Home » Articles » Turkey’s biotech manufacturing ambitions: Yerlika Biopharma’s strategic role ...
Latest features in GaBI Journal, 2023, Issue 3
The articles in this issue of the GaBI ­Journal highlight two important issues that must be considered when reading scient...
Pharmacokinetic bioequivalence studies of a new Etoricoxib tablet formulation developed using proprietary MiST technology — risk assessment and mitigation using GastroPlus software
Author byline as per print journal: Dhananjay Panigrahi1, MPharm; Aditya Murthy2, MPharm, PhD; Shubham Jamdade2, MPharm; M...
Switches between biosimilars and their reference products
Submitted: 22 November 2023; Revised: 24 November 2023; Accepted: 27 November 2023; Published online first: 28 November 20...
Infliximab discontinuation in patients with originator retransition vs. biosimilar continuation
Submitted: 4 November 2023; Revised: 24 November 2023; Accepted: 27 November 2023; Published online first: 28 November 202...
Trends in Saudi FDA drug approvals and GMP inspections: an observational study
Author byline as per print journal: Dr Ali M Alhomaidan; Mohammed Abdulaziz Alageel; Turki Abdulaziz Alrafie; Hassan Moham...
The incorporation of the Halal Management System (HMS) by the pharmaceutical industry
Author byline as per print journal: Ka-Liong Tan1, DPhil; Ainoon Othman1; Irwan Mohd Subri3; Noor Fadzilah Zulkifli1; Mohd...
Biosimilar antibody drug conjugates: considerations of higher order structure and aggregation
Abstract: Undoubtedly the complexity of Antibody Drug Conjugate (ADC) molecules where three components (monoclonal antibod...
Medicare drug price negotiations: impact on healthcare development and patient access to medicines
Author byline as per print journal: Michael S Reilly, Esq; Thomas R Barker, Esq, JD; Charles M Clapton, Steven J Potts, Ph...
Extrapolation requires reading between the lines
The articles in this second issue of 2023 include an Original Research study (Internet questionnaire) of the ‘opinions’ of...
Follow-on biologicals/biosimilars approved in Brazil: May 2023 update
Abstract: Brazilian requirements for approval of biosimilars are aligned with a strict regulatory process and ensure the s...
Ethnic sensitivity assessments in biosimilar monoclonal antibodies clinical development programmes: necessary or not?
Author byline as per print journal: Sandeep N Athalye1, MBBS, MD; Dev B Baruah1, MPharm; Shivani Mittra1, MPharm, PhD; Ank...
Canadian prescribers’ attitudes and perceptions about ophthalmic biosimilars
Author byline as per print journal: Michael S Reilly, Esq; Jane Barratt, PhD Introduction: The first biosimilar entered th...
Statistical tests for detecting reference product change in biosimilar studies
Author byline as per print journal: Jiayin Zheng1, PhD; Peijin Wang2, MS; Yixin Wang3, PhD; Shein-Chung Chow2, PhD Abstrac...
Lagging acceptance of generic and biosimilar drug products; the rest of the story
The articles in this issue of the GaBI Journal reminded me of The Rest of the Story radio programme originally hosted by M...
Non-medical switching of biologicals/biosimilars Canada, Europe and the US: a webinar report
Author byline as per print journal: Michael S Reilly, Esq; Gail Attara; Ralph D McKibbin, MD, FACP, FACG, AGAF; Professor ...
Biosimilars approved in Brazil 2022
Author byline as per print journal: Sílvia Helena Cestari de Oliveira, MSc Abstract: In Brazil, a legal framework for appr...
Pharmacokinetics and relative bioavailability of sitagliptin hydrochloride and sitagliptin phosphate tablets formulations: a randomized, open-label, crossover study in healthy male volunteers
Author byline as per print journal: Chuei Wuei Leong, PhD; Elton Sagim, BBiomedSc, Kar Ming Yee, BPharm; Muhammad Shalhadi...
Biosimilars drug development: time for a paradigm shift?
Author byline as per print journal: Sandeep N Athalye, MS; Shivani Mittra, MPharm, PhD; Ankitkumar M Ranpura, MD Abstract:...
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