Knowledge centre

News & Updates

Selected developments shaping clinical research, bioequivalence and the regulatory environment in Malaysia, ASEAN and beyond.

Latest intelligence

Follow what matters to clinical development.

01

Malaysia & ASEAN

Regional clinical-trial and pharmaceutical developments

Malaysia’s Evolving Rare Disease Ecosystem and the Future of Orphan Drug Access - BioSpectrum AsiaThe Biomedical Industry: Accelerated Upgrade Path (1) - HKTDC ResearchRunning first-in-human clinical trials for drugs in Malaysia - The StarA systematic review and meta-analysis of pharmacy education and practice on prevention and management of noncommunicable diseases in ASEAN countries - Nature
02

Bioequivalence & Complex Generics

Methods, products and development strategy

Bioequivalence assessment between two formulations of a film-coated fixed-dose combination of metformin and vildagliptin (850/50mg) in healthy Tunisian subjects under fed conditions - NaturePharmacokinetic and bioequivalence of two formulations of Valsartan/Amlodipine Tablet(I) in healthy Chinese volunteers: A randomized, three-period, partially replicated crossover study - NatureSix business lessons from Cipla’s nine-decade journey - Express PharmaComplex Generics: Facts, Figures and Who They Benefit - Teva Pharmaceuticals
04

AI in Clinical Research

Technology influencing trial design and delivery

AI in Clinical Trials Doesn’t Have a Capability Problem. It Has a Honesty Problem. - The Clinical Trial VanguardNature Biotechnology | Insilico's AI-Driven IPF Candidate Rentosertib Shows Potential for Biological Age Reversal, as Assessed by Six Proteomic Aging Clocks - kosmo.com.myShaalan Beg: When AI Enters the Clinic - OncodailyAI in clinical trials: Building better trials before they start - pharmaphorum

Authoritative sources

NPRA Malaysia ↗European Medicines Agency ↗US FDA ↗ICH ↗