@article {21, title = {Informed Consent Template by Strategic Initiative for Developing Capacity in Ethical Review. A Good Alternate?}, journal = {PTB Reports}, volume = {4}, year = {2018}, month = {January 018}, pages = {1}, type = {Editorial}, chapter = {1}, abstract = {

Obtaining informed consent from (ICF) the participants of a clinical trial, bioavailability and bioequivalence studies, and investigator initiated research consists of two documents; participants{\textquoteright} information sheet and informed consent form. Informed consent is also a mandate for epidemiological and observational studies. It ensure participants autonomy to enroll them in trials and also legally valid for their post trial access and compensation. As a dictum, it should be in English and vernacular language signed by study subjects or their legally accepted representative (LAR).1 There are valid differences in opinion about amount of information that should be in given consent form. Participant information sheet in too much number of pages is often perceived tedious by the subjects and it is more complex when it comes to countries like India where there is diversity in language.\ Read More ....

}, keywords = {Nil}, doi = {10.5530/PTB.2018.4.1}, author = {Krishnan Vengadaragava Chary} } @article {55, title = {A Unique case of Flunarizine Induced Extrapyramidal Syndrome and Depression}, journal = {PTB Reports}, volume = {2}, year = {2016}, month = {May 2016}, pages = {45-46}, type = {Case Report}, chapter = {45}, abstract = {

Flunarizine is one the cerebroselective calcium channel blocker, commonly prescribed for migraine prophylaxis in neurology clinic. It is considered as non inferior to propranolol and amytriptyline to reduce the frequency of migraine attacks. Here we report a case flunarizine induced extrapyramidal syndrome and depression. A 37 year old female on tablet flunarzine 15 mg daily for her migraine signs of depression and restlessness, propensity to bend, slow reactions and mask face. Depression was rated using patient health questionnaire and extrapyramidal syndrome was diagnosed by modified simpson agnus scale and Barnes akathisia rating scale. Considering nil organic lesion and improvment of all symptoms with the cessation of flunrarizine, case was diagnosed as flunarizine induced depression and extrapyramidal disorder.

}, keywords = {Adverse drug reaction, Drug induced depression, Extra pyramidal Syndrome, Flunarizine, Pharmacovigilance}, doi = {10.5530/PTB.2016.2.6}, author = {Krishnan Vengadaragava Chary and Raman Krishnan} }