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Post History: Chief Pharmacist
Short answer: No.
And USP <1236> is very clear on this point.
Apparent solubility and …In: Apparent solubility and Equilibrium solubility
1 month ago
This question has become increasingly common in the post-Brexit regulatory environment, especially f …In: Bridging Study for EU and UK
2 months ago
Yes. But only if you meet the prerequisites.
Read details: https://pharmatopics.com/does-f2-apply-t …In: F2 Value
2 months ago
This is a certification course on GLP containing basic knowledge of Good Laboratory Practice (GLP) i …In: Pharmacy Course
2 months ago
We typically expect photodegradation only for molecules that absorb light directly at or above 320 n …In: Stability Study
2 months ago
1. FDA Draft Guidance (1999): ANDAs – Blend Uniformity Analysis
This was one of the earliest formal …In: Blend Uniformity (BU) Guidelines
2 months ago
Check it: https://courses.pharmalesson.com/courses/pharmacist-licensure-exam-preparation/
This is a …In: NAPLEX
3 months ago
Uniform flow is essential for consistent die filling on high-speed tablet presses. An optimized PSD …In: PSD
3 months ago
Hiring an FDA regulatory consultant is a strategic decision that depends on where you are in your pr …In: FDA Regulatory Consultant
4 months ago
WHO Prequalification is not exactly a "GMP accreditation" in the sense of a standalone cer …In: WHO Prequalification
4 months ago
You should consider following points for drug-layer coating:
API solubility in coating solution
…In: Drug-Layer Tablet
4 months ago
There is no requirement for in-use stability study on a bottle of tablet or capsule. It is speciall …In: In use study for a bottle of capsules
6 months ago
You can do risk assessment considering:
Molecule stability data
Product stability data
Product …In: Manufacturing Area RH & Temperature excursion allowable time
8 months ago
There is another course on pharma lesson for pharmacist licensure exam preparation:
https://courses …In: Study Materials
11 months ago
12 months ago
@ariyan
You should prioritized below topics:
ALCOA+https://www.pharmaspecialists.com/2022/02/alc …In: QA Job Preparation
12 months ago
You can find here:
https://courses.pharmalesson.com/course-tag/certification-course/In: Pharmacy Course
12 months ago
Basic learning topics for QC job seekers:
1. QC Equipment Listhttps://www.pharmaspecialists.com/202 …In: QC Job Preparation
1 year ago
I think, you may want to know about peak vessel. It is used to overcome the coning problem arise dur …In: Dissolution Vessel Size
1 year ago
Discriminating dissolution media used to identify the differences in the dissolution performance of …In: Discriminating Dissolution Media
1 year ago
Dissolution vessels come in various sizes, although the standard size is 1 litre. Other available si …In: Dissolution Vessel Size
1 year ago
HPLC calibration parameters typically include:A. Pump1. Flow Rate Accuracy2. Flow Rate Consistency3. …In: HPLC Calibration
1 year ago
1. ISO 9001 – Quality Management System (QMS)2. ISO 14001 – Environmental Management System (EMS)3. …In: ISO Guidelines
1 year ago
You can follow the health Canada guidance:
https://www.canada.ca/en/health-canada/services/drugs-h …In: Critical Parameter of Cleaning process
1 year ago
A visual inspection is performed after a cleaning operation at dried condition of the equipment and …In: Rinse sampling for Cleaning validation
1 year ago
BASICS RULES OF GLP
1) Make sure to have the correct written procedure/instructions before starting …In: GLP
1 year ago
I hope below contents will be helpful:
Key Elements of a Bioequivalence Study Strategy
Bioequiva …In: Bioequivalence Study
1 year ago
I hope below article will be helpful for you -
https://pharmadigests.com/basic-guideline-for-promet …In: DHA & MOH
1 year ago
Check the below link:
https://pharmaexams.com/formulation-development-interview-questions-and-answe …In: Formulation Development Job Preparation
1 year ago
Hi @ariyan,
Please find the below source of free online pharmacy courses:
https://courses.pharmadi …In: Pharmacy Course
1 year ago
You can check the below topics:
1. Good Design Practicehttps://www.pharmaspecialists.com/2023/10/go …In: Pharmaceutical Manufacturing Study Topics
1 year ago
Drug-layer coating is usually performed for such products which are showed incompatibility in conven …In: Drug Layer Coating
1 year ago
Half-life is useful for determining excretion rates as well as steady-state concentrations for any s …In: PK Parameters for BE Study
1 year ago
You can check the below database:
https://www.pharmaspecialists.com/p/available-bcs-classificatio …In: BCS Classification Database
1 year ago
Major areas of R&D can be inspected:
Analytical method transfer & validation area
Stabil …In: FDA Audit in R&D
1 year ago
You can follow the below topics:
1. Good Design Practicehttps://www.pharmaspecialists.com/2023/10/g …In: Pharmaceutical Production Job Preparation
1 year ago
Optimum spray rate, inlet temperature and product temperature can reduce the loss of API during drug …In: Drug Layer Coating
1 year ago
Common DI issues in pharma:
Backdating
Data is not legible
Overwriting
Wrong data
Data missi …In: Common DI Issues
1 year ago
Usually following parameters are measured in bioequivalence study:
AUC(0-t)
AUC(0-∞)
Cmax
tmax …In: PK Parameters for BE Study
1 year ago
Please find the below FDA guidelines regarding ANDA:
ANDA Submissions — Amendments to Abbreviated …In: FDA Guideline for ANDA Submission
1 year ago
@ariyan
Refer to below articles:
Formulation Development Strategy for BCS Class I Molecules
For …In: Preformulation Study
1 year ago
You can check it: https://pharmaexams.com/pharmaceutical-production-interview-questions-and-answers/ …In: Pharmaceutical Production Job Preparation
1 year ago
A sample of the rinse or swabbing solvent should always be based on the type of testing to be perfor …In: Suitable Diluent selection for swab & rinse sampling
1 year ago
EDQM = European Directorate for the Quality of Medicines & HealthCare.
The EDQM contributes to …In: EDQM
1 year ago
Here is the details guideline:
https://cdn.who.int/media/docs/default-source/medicines/norms-and-st …In: WHO Guideline for Technology Transfer
1 year ago
List of ICH Q Guidelines:
ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
IC …In: ICH Q Guidelines
1 year ago
In general, “significant change” for a drug product is defined as:
A 5% change in assay from its …In: Stability Study
1 year ago
@ariyan
Refer to below articles:
Formulation Development Strategy for BCS Class IV Molecules
So …In: Preformulation Study
1 year ago
