DIPSAR was amongst the first few institution to start M. Pharm. in Clinical Research Course since 2004. Five students are admitted each year. The Students are taught clinical research with emphasis on various Phases of clinical trials, Preclinical regulatory requirements as per schedule Y, Patient Recruitment and Retention Regulations for conducting clinical trials as per USA-FDA, MHRA, ICH and Japan. Students undergo protocol designing for IND filing, Roles and Responsibility of ethics committee & compensation in clinical trials. Role of CRO, sponsors and Principal Investigators for conducting clinical trials are also covered in the syllabus. They are given practical exercise on patient information sheet informedconsent and designing of Protocols for IND submission.In addition students are exposed to Pharmacovigilance, its need and importance as per PvPI, UMC & Pharmacovigilance system in various Countries. The Course also covers the Pharmacoeconomics & OutcomesResearch – Basic Principle of Pharmacoeconomics, Patients reported outcomes, Systemic review & Meta-analysis. So far about 65 Candidates have successfully completed their masters in Clinical Research & all of them arewell placed in various prestigious Pharmaceutical Industries. In fact most of the students are placed in the second year itself. It is recognized one of the most successful course in Clinical Research all over the Country. Division of clinical pharmacy published 3 books namely, Basic Principles of Clinical Research, Drug Discovery and Clinical Research and Pharmacovigilance and drug screening Methods which is Widely referred as text books both in Academia and Industry. It could also established the 1st National Pharmacovigilance Centre at AIIMS 1998, in collaboration with WHO and from 2011 the division has contributed significantly to PvPI. This has become the most vibrant Pharmacovigilance program globally. In view of the contributions, a wing at IPC (PvPI) has been dedicated as Suresh Kumar Gupta wing for Pharmacovigilance. In addition, this division established pharmacoeconomics and outcomes research at DIPSAR, which is one of the most emerging fields in the Country and offers an excellent opportunity for pharmacist. For the past five years with exposure to this field, more than 15 students have been placed in the industry with the best perks available to them. Only Institute where students have been trained in this subject.
Development of Novel Nanoformulations
The research activities at DPSRU and DIPSAR encompass pharmaceutical technology, synthesis and analytical techniques, pharmacotherapeutics, standardization of herbal actives and protocols adopted to comply with regulatory milieu of region/country concerned. The formulation development is aimed to design diverse preparations as nanoparticles, vesicles (ethosomes, bilosomes, transferosomes), gels etc. Using polymers chitosan and Eudragit biosomes were fabricated for pravastatin via nanoparticles. Attempts are also made to fabricate bilosomes for delivery of glycopeptides. Peptides are embedded as scaffolds in tissue engineering. Vesicular systems containing salbutamol, curcumin, voriconazole are formulated for transdermal application. The polymeric hemostatic scaffolds purported to act as wound healing, antibacterial, antifungal and local anesthetics were prepared. The gel formulation possessing stimulus sensitive activity (i.e. temperature) was prepared meant for ocular delivery of brimonidine. Similarly, variety of nanometric architects were formulated for control of glaucoma. The principles of Quality by Design (QbD) approach were applied while developing certain dosage forms. Interestingly, effervescent tablets containing green tea extract, consumption of which is in vogue due to its anti-ageing, anti-obesity attributes, were developed and evaluated.
Drug Discovery through Synthetic Chemistry
The chemical classes selected and optimized by evaluation embrace benzimidazole derivatives, benzothiazole derivatives, benzoxazole, fatty acid derivatives, β-ionone derived chalcones, Mannich base derivatives etc. Analytical assessment was carried out to quantify antidiabetic drugs, antioxidant components of green tea and their stability-indicating assay as well. Moreover, the bioanalytical method development was undertaken to assess drug content in plasma, serum by HPLC, MS. The major areas covered under pharmacological investigations were anticancer, neuroprotective, stress triggered ailments, diabetic cardiomyopathy and fructose induced metabolic syndrome. The plants selected were Cannabis sativa, Stevia, Glycyrrhiza glabraetc. Themedicinalfeaturesofherbal produce are systemically elucidated via thorough pharmacognostical evaluation techniques, hichinvolvephysicochemical characterization, biological activity determination. The plants which were investigated include Pistacia integerrum, Cucurbita pepo, Plumerica obtusa. Further, determination of antihypertensive and cardiotonic functions of plants is on.\
Regulated Studies for New Drugs
The studies are carried out to compare the prevailing regulations, approaches and challenges while registration of drug products, fixed drug combinations and intra uterine devices (IUDs). Subsequent to drug product/medical device then comes its promotion at various levels by a number of strategies. The impact of e-health and m-health apps was assessed on their terminal users.