Abstract: Author byline as per print journal: Dr Ali M Alhomaidan; Mohammed Abdulaziz Alageel; Turki Abdulaziz Alrafie; Hassan Mohammed Alqarni; Ibraheem Yahya Khbrani; Dalal J Alkhamis; Mohammed F Alkhalifah; Abdualmajeed S bin Jumaiah; Dr Mohammed A Dahhas Abstract: The Saudi Food and Drug Authority’s (SFDA) pharmaceutical products approval and regulation procedures have changed and become more …The post Trends in Saudi FDA drug approvals and GMP inspections: an observational study first appeared on GaBI Journal. PubDate: Wed, 18 Oct 2023 08:04:04 +000
Abstract: The articles in this second issue of 2023 include an Original Research study (Internet questionnaire) of the ‘opinions’ of Canadian ophthalmologists, a Review Article describing a statistical method to assess the ‘drift’ in the attributes of a reference, originator biological product, a Perspective (opinion) article questioning the value of ethnic sensitivity studies (ESS) in the …The post Extrapolation requires reading between the lines first appeared on GaBI Journal. PubDate: Thu, 14 Sep 2023 13:34:20 +000
Abstract: Author byline as per print journal: Michael S Reilly, Esq; Thomas R Barker, Esq, JD; Charles M Clapton, Steven J Potts, PhD, MBA; Andrew Spiegel, Esq Introduction: In the US, a Medicare price negotiation provision has been introduced in the form of the 2022 Inflation Reduction Act (IRA). An online webinar on the introduction of …The post Medicare drug price negotiations: impact on healthcare development and patient access to medicines first appeared on GaBI Journal. PubDate: Thu, 14 Sep 2023 13:25:11 +000
Abstract: Abstract: Undoubtedly the complexity of Antibody Drug Conjugate (ADC) molecules where three components (monoclonal antibody, cytotoxic drug and appropriate linker) are involved poses a challenge for biosimilar development. As with all biomolecule development, both novel and biosimilar, it is important to choose orthogonal analytical techniques to interrogate Quality Attributes, particularly for Higher Order Structure (HOS) …The post Biosimilar antibody drug conjugates: considerations of higher order structure and aggregation first appeared on GaBI Journal. PubDate: Thu, 14 Sep 2023 12:59:06 +000
Abstract: Author byline as per print journal: Ka-Liong Tan1, DPhil; Ainoon Othman1; Irwan Mohd Subri3; Noor Fadzilah Zulkifli1; Mohd Mahyeddin Mohd Salleh3; Nazariyah Yahaya4; Khairun Nain Nor Aripin1; Shahirah Nadiah Shaharuddin5; Seri Azalina Mohd Ghazalli6; Muhammad Syazan Sulaiman6 Abstract: In recent years there has been a rapid growth of the halal pharmaceutical industry, especially in the supply …The post The incorporation of the Halal Management System (HMS) by the pharmaceutical industry first appeared on GaBI Journal. PubDate: Thu, 14 Sep 2023 12:53:33 +000
Abstract: Author byline as per print journal: Sandeep N Athalye1, MBBS, MD; Dev B Baruah1, MPharm; Shivani Mittra1, MPharm, PhD; Ankit Ranpura1, MD; Kuldeep Kumar1, PhD; Elena Wolff-Holz2, MD Abstract: Ethnic sensitivity assessments in the form of bridging pharmacokinetics (PK) studies are often needed for biosimilar monoclonal antibodies (mAbs) to meet regulatory requirements in regions like East … PubDate: Tue, 08 Aug 2023 07:52:31 +000
Abstract: Author byline as per print journal: Jiayin Zheng1, PhD; Peijin Wang`2, MS; Yixin Wang3, PhD; Shein-Chung Chow2, PhD For the biosimilarity assessment between a test product and a reference product, the US Food and Drug Administration (FDA) recommends a stepwise approach for obtaining totality-of-the-evidence in support of regulatory approval of the submission. The stepwise approach … PubDate: Thu, 04 May 2023 15:36:03 +000
Abstract: Author byline as per print journal: Michael S Reilly, Esq; Jane Barratt, PhD Introduction: The first biosimilar entered the Canadian market in 2009 and the first ophthalmic biosimilar was approved in 2022. In 2022, the Alliance for Safe Biologic Medicines (ASBM) and the International Federation on Ageing (IFA) asked prescribing ophthalmology physicians in Canada for their … PubDate: Thu, 04 May 2023 15:12:55 +000
Abstract: The articles in this issue of the GaBI Journal reminded me of The Rest of the Story radio programme originally hosted by Mr Paul Harvey that started each episode with, ‘And now for the rest of the story’. This is because these articles illustrate that sometimes what is not discussed in an article can be … PubDate: Wed, 03 May 2023 14:02:29 +000
Abstract: Abstract: Brazilian requirements for approval of biosimilars are aligned with a strict regulatory process and ensure the same high standards of quality, safety and efficacy as for originator biologicals. Submitted: 29 September 2022; Revised: 26 January 2023; Accepted: 27 January 2023; Published online first:9 February 2023 In Brazil, a legal framework for approving follow-on biological products using … PubDate: Thu, 02 Mar 2023 10:49:52 +000
Open Access journal
