Overcoming Challenges in a Bioequivalence Assessment Study o...
29 Aug 2023
The study aimed to compare the bioavailability and characterize the pharmacokinetic profile of Octreotide Acetate Microspheres for intramuscular Inje...
Non – LCMS, Non – LBA Based Challenging and Innovative B...
01 Jun 2020
Non – LCMS, Non – LBA Based Challenging and Innovative Bioanalytical Methods...
WHO Expert Committee (Fiftieth report): Clinical recommendat...
08 Jul 2019
WHO has recently released a guideline for performing in vivo bioequivalence studies (WHO Technical Report Series 996, 2016). The guideline mainly emph...
Clinical Research: A Tool to Support Nutraceutical Product C...
03 Jun 2019
Nutraceuticals are the products that have both nutritional and pharmaceutical characters. Therefore they are used as a dietary supplement to modulate ...
REMS/RMP Requirement and its Consideration in Clinical Studi...
05 May 2019
Drugs used in therapeutic treatments have associated potential risks for adverse events (AE). Nevertheless, medical practitioners acknowledge such ris...
WHO Draft Guidance for Organizations Performing In Vivo Bioe...
07 Mar 2019
The guidance covers major amendments; the points regarding the clinical study part are mentioned below: The CRF should be sent to the IEC for review...
PHASE-0 (MICRO-DOSING): A NEW APPROACH
08 Apr 2018
Developing and launching a new pharmaceutical drug to the market is an immensely expensive operation. Pharmaceutical scientists and physicians are con...
FDA DRAFT GUIDANCE for recording "Minutes of Institutional R...
06 Mar 2018
I. IRB must prepare and maintain adequate documentation of IRB activities, including minutes (MOM) in sufficient detail to show: Attendance, actions b...
BE Studies of Inhaled Drug Products - Challenges and Strateg...
06 Mar 2018
In the recent disease management scenario, inhaled drug products are playing a significant role in therapeutics. Inhalational route of drug delivery h...
