Chào mừng bạn đến với Website NGHIÊN CỨU BÀO CHẾ THUỐC
Rất nhiều ưu đãi và chương trình khuyến mãi đang chờ đợi bạn
Ưu đãi lớn dành cho thành viên mới
  • 5
    Xem tất cả
  • Giỏ hàng
    Tổng tiền:

    Không có sản phẩm nào trong giỏ hàng của bạn

  • Trang chủ
  • Phan-mem
  • Guide to Dissolution Data for a Single Drug in PharmApp: Dissolution ↔ DailyMed ↔ RxNorm ↔ NDC/Orange Book

Guide to Dissolution Data for a Single Drug in PharmApp: Dissolution ↔ DailyMed ↔ RxNorm ↔ NDC/Orange Book

14/01/2026
Admin

 

Guide to Dissolution Data for a Single Drug in PharmApp: Dissolution ↔ DailyMed ↔ RxNorm ↔ NDC/Orange Book



Guide to Dissolution Data for a Single Drug in PharmApp: Dissolution ↔ DailyMed ↔ RxNorm ↔ NDC/Orange Book

This guide walks you through an end-to-end, practical workflow to search and analyze dissolution-method data for one specific drug in PharmApp—starting from FDA Dissolution Methods and extending to DailyMed SPL/SETID linking, RxNorm enrichment, NDC retrieval, and (when available) Orange Book joining.
You can follow the same steps for any drug. In this example, we use Metformin.

What You Will Achieve

By the end of this guide, you will be able to:

  • Find a drug’s records in FDA Dissolution Methods
  • Link those records to DailyMed and obtain SETID/SPL context
  • Enrich the dataset with:
    • RxNorm concepts (RXCUI, RXSTRING, RXTTY)
    • NDC lists (from DailyMed Web Services where applicable)
    • Application numbers (when available)
    • Orange Book data (when appl_no_norm can be resolved)
  • Validate the final output using Gold QA/Contract
  • Query results quickly via the Gold SQLite index

Step 0 — Log in to PharmApp

  1. Open your browser and go to https://www.pharmapp.vn/
  2. Sign in with your PharmApp account.
  3. After login, ensure you are in a workspace where modules are visible (commonly All Modules).

Tip: If you do not see the modules described below, check your workspace selection and account permissions.

Step 1 — Find the Dissolution Modules

On the PharmApp home/modules screen:

  1. Use the module search field (or scroll) and type: Dissolution
  2. You should see a group of modules similar to:
    • FDA Dissolution Methods
    • FDA Dissolution Methods KB
    • Dissolution DailyMed Link Phase 1.6
    • Dissolution DailyMed Link Phase 2.7
    • FDA Dissolution Analytics Dashboard
    • Dissolution Download Center (Phase 3.5)
    • Dissolution DailyMed RxNorm NDC OB Phase 3.5
    • Dissolution Gold Contract QA Phase 4
    • Dissolution Integration Monitor Diff Phase 5.5

This guide follows the recommended operational order.

Step 2 — Search the Drug in FDA Dissolution Methods

Module: FDA Dissolution Methods

  1. Open FDA Dissolution Methods
  2. In the main search/keyword input, type your drug name (INN preferred):
    Example: Metformin
  3. Review the returned table rows—depending on your module view, you may see fields related to:
    • Dosage form and route
    • Apparatus type
    • Dissolution media
    • RPM and time points
    • Other method conditions

Expected outcome: You can identify one or more records associated with your drug.

If you see no results:

  • Try a simplified name (remove salt form, e.g., “metformin hydrochloride” → “metformin”)
  • Try alternative spelling or capitalization

Step 3 — Confirm DailyMed Has SPL Coverage (Offline Index)

Module: Dissolution DailyMed Link Phase 1.6

This step verifies that DailyMed has SPL entries for your drug and that your offline index can resolve them.

  1. Open Dissolution DailyMed Link Phase 1.6
  2. Use the search field and enter: Metformin
  3. Confirm you can retrieve relevant SPL entries (and ideally capture a SETID)

Expected outcome: At least one matching SPL appears for your drug.

Note: If this is your first run, Phase 1.6 is typically where you build or verify the DailyMed SQLite index used for fast offline lookup.

Step 4 — Link Dissolution ↔ DailyMed (Generate Linked Dataset)

Module: Dissolution DailyMed Link Phase 2.7

This module performs the linkage between FDA Dissolution Methods records and DailyMed SPLs/SETIDs.

  1. Open Dissolution DailyMed Link Phase 2.7
  2. Select your input source (typically latest or a specific snapshot of Dissolution Methods)
  3. Run the linking process (matching/linking button)
  4. After completion, locate the linked output and filter/search for Metformin within the results (if filtering is available in the UI)

Expected outcome:

  • Your drug’s records now include a DailyMed SETID (or an equivalent SPL identifier field)

Step 5 — Enrich with RxNorm, NDC, Application Numbers, and Orange Book

Module: Dissolution DailyMed RxNorm NDC OB Phase 3.5

This is the main enrichment step that produces the most complete dataset.

  1. Open Dissolution DailyMed RxNorm NDC OB Phase 3.5
  2. Choose the Phase 2.7 linked dataset as input
  3. Run the enrich steps in this recommended order:
    • RxNorm mapping → adds RXCUI (and related fields)
    • DailyMed Web Services enrichment → retrieves NDC lists and application numbers (when available)
    • Orange Book join → attempts to match using normalized application number (appl_no_norm)
  4. Filter/search for your drug (e.g., Metformin) in the enriched output table

Expected outcome: You should see additional fields populated, commonly including:

  • rxcui
  • ndc_list_json (or equivalent NDC list field)
  • appl_no_norm (when resolvable)
  • Orange Book fields (when join succeeds)

Important note: Orange Book joining is not guaranteed for every record. Some products may not carry resolvable application numbers or may not map cleanly.

Step 6 — Validate and Query via Gold (Contract + QA + SQLite)

Module: Dissolution Gold Contract QA Phase 4

This step turns your enriched dataset into an auditable “Gold” artifact and creates a SQLite index for fast searching.

  1. Open Dissolution Gold Contract QA Phase 4
  2. Run the Phase 4 build actions (as exposed in your UI), which typically create:
    • Gold Contract JSON
    • Gold QA JSON
    • Gold SQLite index (e.g., dissolution_dailymed_links_gold.sqlite)
  3. Use the SQLite query capability (either in Phase 4 UI or in a linked explorer module, if provided):
    • Search “Drug contains” → type metformin

Expected outcome:

  • Fast lookup results without needing to load the entire parquet into memory
  • You can quickly retrieve and copy key identifiers such as SETID, RXCUI, and application number

Step 7 (Optional) — Monitor Changes Across Runs (Regression Detection)

Module: Dissolution Integration Monitor Diff Phase 5.5

If you refresh data periodically, you should monitor whether coverage or quality decreases over time.

  1. Open Phase 5.5
  2. Configure thresholds (for example, alert if coverage drops by more than 1%)
  3. Choose a Baseline run and a Current run
  4. Compute the diff and review:
    • Coverage deltas (SETID/RXCUI/NDC/Orange Book)
    • QA and Contract status changes
    • Saved diff/snapshot artifacts for audit trails

Expected outcome: You can detect regressions early and keep your pipeline stable.

What “Success” Looks Like

You can consider the “single drug search” successful when:

  • The drug appears in FDA Dissolution Methods
  • Linked output includes a DailyMed SETID/SPL identifier
  • Enrichment populates at least one of:
    • RXCUI
    • NDC list
    • appl_no_norm (enabling Orange Book joining)
  • Gold QA/Contract is generated and the drug can be queried via Gold SQLite

Recommended Drugs for First-Time Demo

For the highest chance of seeing complete mapping coverage, start with widely used INNs such as:

  • Metformin
  • Atorvastatin
  • Amlodipine
  • Omeprazole
  • Losartan