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Transforming healthcare: CinnaGen’s leadership in follow-on biologicals/biosimilars development and market expansion
Abstract: CinnaGen, the largest biopharmaceutical company in the MENA region, is a leader in developing follow-on biologic...
A review of international initiatives on pharmaceutical regulatory reliance and recognition
Abstract: In light of recent global health challenges, the need for regulatory reliance – where one regulatory authority a...
Comment on the article by Reilly MS and McKibbin RD
Abstract: Reilly and McKibbin oppose the update of FDA interchangeability guidance that does not require clinical switch s...
Comment on ‘Misinformation about interchangeable biosimilars’
Author byline as per print journal: Hillel P Cohen, PhD; Caridad Pontes, MD, PhD; Fernando de Mora, MBA, PhD Abstract: The...
Third and final issue of GaBI Journal’s 13th volume
This third issue of GaBI Journal is the last of the volume for this year and marks the end of the first year of me taking ...
Physicochemical stability of Etoposide Accord in punctured original vials and after dilution with 0.9% sodium chloride or 5% glucose solution
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
Physicochemical stability of Doxorubicin Accord 2 mg/mL in punctured original vials and polypropylene syringes and after dilution with 0.9% sodium chloride or 5% glucose solution in polyethylene bottles
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
Physicochemical stability of Epirubicin Accord 2 mg/mL in punctured original vials and polypropylene syringes and after dilution with 0.9% sodium chloride or 5% glucose solution in polyolefine bags
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
Physicochemical stability of Docetaxel Accord 20 mg/mL concentrate diluted with 0.9% sodium chloride or 5% glucose solution in non-PVC bags
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
Physicochemical stability of Cytarabine Accord in punctured original vials and after dilution with 0.9% sodium chloride solution in polyolefine bags
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
Physicochemical stability of Cisplatin Accord in punctured original vials, syringes and after dilution with 0.9% sodium chloride solution
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
Physicochemical stability of Carboplatin Accord in punctured original vials, syringes and after dilution with 0.9% sodium chloride or 5% glucose solution
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
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
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To deter...
Physicochemical stability of Bortezomib Accord 2.5 mg/mL and diluted 1 mg/mL intravenous injection solution in punctured original vials and polypropylene syringes
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Abstract: This study asses...
Physicochemical stability of Azacitidine Accord 25 mg/mL suspension for injection in original vials and polypropylene syringes after reconstitution with refrigerated water for injection
Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Abstract: The physicochemi...
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:...
Response to the Opinion entitled ‘Biosimilars drug development: time for a paradigm shift?’
Abstract: The Opinion published in this issue of GaBI Journal titled 'Biosimilars drug development: time for a paradi...
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