Write in detail about basic tests for analysis of a pure pyto-pharmaceutical.
[6 marks]Suggest assessment criteria of a powdered herb drug using WHO guidelines.
[5 marks]Give specifications of following parameters with their limits suggested by WHO guidelines; Microbial limit, Heavy metal residues.
[5 marks]Elaborate Good cultivation practice criteria for cultivation of medicinal plants; site selection, Ecological environment social impact and soil selection
[6 marks]Write a note on Good Collection Practice for Wild medicinal plants.
[5 marks]Explain in detail about ideal Post Harvesting processes suggested by WHO guidelines.
[5 marks]Write in brief about ICH guidelines for stability studies of new dosage form.
[6 marks]Explain in detail how EU guideline differs from ICH guidelines.
[5 marks]Write applications of HPLC and HPTLC techniques in standardization of herbal products.
[5 marks]Enlist the documents required for New Drug Application of a plant bio-active.
[6 marks]Write detailed OECD guidelines for acute toxicity study of unknown herb.
[5 marks]Explain LD determination study guidelines for pyto-constituent.50
[5 marks]Write a short note on Phyto-pharmacovigilance.
[6 marks]Enlist types of markers and their significance in Medicinal plant studies.
[5 marks]Write detailed frame work of Adverse Drug Reporting. Q. 6 (a) Describe following subparts of cGMP; 1. Building 2. Equipments 3. Personell
[6 marks]Enlist suitable WHO and Indian guidelines for Records and report maintenance in Herbal Drug Industry.
[5 marks]Suggest Good Laboratory Practice guidelines for a Natural Product Industry.
[5 marks]List out different Herbal Pharmacopoeias with their comparative components of monograph.
[6 marks]Give details of requirements for Export approval of a Herbal supplement.
[5 marks]Write a short note on guidelines for Efficacy evaluation given by CDSCO.
[5 marks]