Choosing the Right Imaging Method to Produce Tissue Distribution Data
Introduction: From “Cut and Burn” to Cryosections The nomination of a new chemical entity, or NCE, during drug development triggers a cascade of activities…
Confidently Choose A CRO to Support Your IND Efforts
3 Simple Tips For Finding A CRO With IND Application Knowledge The U.S. Food and Drug Administration (FDA) reports having received a higher number…
Three Key Brexit Issues Driving the Relocation of UK-Based Preclinical and Bioanalysis Research Projects
Biosimilars And Gene Therapy Treatments Are Poised For Growth. Will The Uk Miss Out? On the heels of recent FDA approvals of gene therapies…
Overcoming Pediatric Trial Challenges
Since the enactment of the FDA Safety and Innovation Act (FDASIA) in 2012, the demand for pediatric clinical trials has increased. Pediatric trials are…
Human Mass Balance Studies
About Human Ame (hAME) Studies Before a drug receives marketing approval and is made available to patients, it has to be extensively studied in…
Antibody-Drug Conjugates (ADCs) in Oncology Drug Development
The Antibody-Drug Conjugate Oncology Drug Development Challenge Antibody-drug conjugates (ADCs) uniquely target cancer cells by combining the precision of monoclonal antibodies, which identify the…
Biosimilar Drug Development
Economic Importance And Financial Impact Of Healthcare In recent years, the pharmaceutical industry has witnessed increased political interest and attention due to the increased…
Pharmacokinetic Studies in Patients
Studies In Patients Versus Healthy Volunteers Sometimes practical or ethical considerations dictate whether healthy volunteers or patients should be recruited for a particular study….
RNAi Therapeutics
The Birth Of RNAi The Nobel Prize for the discovery that double-stranded RNAs (dsRNAs) can trigger silencing of complementary messenger RNA sequences was awarded…
Seeking Drug Approval via the 505(b)(2)NDA Option
The 505(b)(2) Pathway Today, many pharmaceutical companies – generic or innovative, large or small, privately held or publicly traded – are choosing the 505(b)(2)…