article thumbnail

Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

Key Requirements for Generic Drug Approval Bioequivalence Studies : The PMDA requires bioequivalence studies to ensure that the generic drug is equivalent to the RLD in terms of its pharmacokinetic and pharmacodynamic properties.

article thumbnail

The rising impact of biomarkers in early clinical development

Drug Target Review

In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent). Trial design and statistical methods are also key to determining the utility and validity of biomarkers.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Biogen Advances Investigational SMA Therapy to Registrational Trials After Positive Phase 1 Data

The Pharma Data

The goal is to boost SMN protein production more effectively and offer a more convenient, once-a-year dosing schedule , thereby improving long-term disease management and patient compliance. The study included two parts: Part A : A randomized, placebo-controlled segment in healthy adult male volunteers.

article thumbnail

Toxicology transformed: Why accuracy now leads the way

Drug Target Review

For these studies, a comprehensive approach to drug metabolism and pharmacokinetics (DMPK), along with immunogenicity is essential, drawing on expertise from multiple disciplines. Special attention is required when dealing with antibody-based therapeutics due to their high susceptibility to biotransformation.

article thumbnail

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

Our experts stay up to date on all new and evolving regulations to guarantee regulatory compliance in your studies. An oligonucleotide is a short strand of nucleotides, the building blocks of DNA or RNA, used in genetic research and therapy.

article thumbnail

Time for change: non-human primates in drug research

Drug Target Review

Their unique suitability has made them valuable for evaluating pharmacokinetics, toxicology and safety in drug candidates before human clinical trials. Rising costs and regulatory hurdles Ensuring NHP welfare comes at a significant financial and operational cost.

article thumbnail

Navigating Regulatory Hurdles in Drug Development

DrugBank

The failure rate in clinical trials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance. Regulatory agencies require pharmaceutical companies to submit preclinical and clinical trial data covering toxicology, pharmacokinetics, pharmacodynamics, and long-term safety monitoring.